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Health product recall

Smith & Nephew, Inc. Hip Replacement Parts - Part II (2016-06-24)

Starting date:
June 24, 2016
Posting date:
July 20, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59366

Affected Products

  1. ECHELON BOWED - CEMENTED FEMORAL STEM
  2. BASIS 12/14 TAPER PRIMARY COLLARED STEMS - COBALT CHROME
  3. RADIAL HEAD PROSTHESIS (CO-CR)
  4. REFLECTON ACETABULAR SYSTEM - 3 HOLE SHELL
  5. REFLECTION ACETABULAR SYSTEM - NO HOLE SHELL
  6. REFLECTION ACETABULAR SYSTEM - HA COATED 3-HOLE SHELL
  7. REFLECTION ACETABULAR SYSTEM - SCREW HOLE COVER
  8. REFLECTION ACETABULAR SYSTEM - SPIKED SHELL
  9. REF. ACETABULAR SYS REF. 10 MRAD CROSS-LINKED POLYETHYLENE ACETAB. LINERS
  10. REFLEC. ACETABULAR SYS REF. 10 MRAD CROSS-LINKED POLYETHYLENE ALL POLY CUPS
  11. CPCS TOTAL HIP SYSTEM - COCR PRIMARY
  12. REFLECTION CERAMIC HIP SYSTEM - REFLECTION FSO 5 ACETABULAR TI SHELLS
  13. REFLECTION CERAMIC HIP SYSTEM - REFLECTION INTERFIT ACETABULAR SHELLS
  14. REFLECTION CERAMIC HIP SYSTEM - ALUMINA INSERTS (28MM ID.) - CERAMIC
  15. REFLECTION CERAMIC HIP SYSTEM - ALUMINA INSERTS (32MM ID.) - CERAMIC
  16. CPCS TOTAL HIP SYSTEM - SS PRIMARY
  17. CPCS TOTAL HIP SYSTEM - SS FEMORAL HEAD
  18. ZIRCONIUM ALLOY OXINIUM FEMORAL HEAD
  19. ECHELON HIP SYSTEM - POROUS PLUS HA STRAIGHT STEMS W/ COLLAR
  20. ECHELON HIP SYSTEM - POROUS PLUS HA STRAIGHT STEMS W/ CALCAR COLLAR
  21. REFLECTION ACETABULAR SYSTEM - MULTI-HOLE SHELL
  22. REFLECTION ACETABULAR SYSTEM - HA PERIPHERAL HOLE SHELL
  23. SYNERGY HIP SYSTEM - HA COATED POROUS FEMORAL STEMS W/STANDARD OFFSET
  24. COBALT CHROME FEMORAL HEAD
  25. OPTI-FIX HIP SYSTEM - OPTI-FIX LINER
  26. OPTI-FIX HIP SYSTEM - OPTI-FIX XLPE LINER
  27. REFLECTION ACETABULAR SYSTEM - HA MULTI-HOLE SHELLS
  28. REFLECTION 3 ACETABULAR SYSTEM - MULTI-HOLE ACETABULAR SHELL
  29. OXINIUM MODULAR FEMORAL HEAD
  30. COCR MODULAR FEMORAL HEAD
  31. SMF HIP STEM SYSTEM - STEM WITH STIKTITE STANDARD OFFSET
  32. SMF HIP STEM SYSTEM - STEM WITH STIKTITE HIGH OFFSET
  33. SMF HIP STEM SYSTEM - STEM WITH STIKTITE
  34. REDAPT REVISION FEMORAL SYSTEM PROXIMALLY FLUTED REVISION STEM
  35. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVED REVISION
  36. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVE STIKTITE W/ HA
  37. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVE GRIT-BLASTED W/HA
  38. REDAPT SLEEVELESS MONOLITHIC REVISION STEM

Reason

Smith & Nephew, Inc. has initiated a voluntary field safety corrective action/recall of the ceramic hip prostheses. The current hip prostheses IFUs do not provide adequate instruction on the revision surgeries due to ceramic failure. The IFU does not provide the detailed instructions that if a hip prostheses revision is required due to a fractured ceramic component, revisions shall only be performed using a ceramic femoral ball head in order to prevent any potential undue wear of the revision components.

Affected products

BA. ECHELON BOWED - CEMENTED FEMORAL STEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71314112
  • 71314114
  • 71315112
  • 71315114"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BB. BASIS 12/14 TAPER PRIMARY COLLARED STEMS - COBALT CHROME

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7131-2261
  • 7131-2262
  • 7131-2263
  • 7131-2264
  • 7131-2265"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BC. RADIAL HEAD PROSTHESIS (CO-CR)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71927094
  • 71927095
  • 71927096
  • 71927097"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BD. REFLECTON ACETABULAR SYSTEM - 3 HOLE SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71336442
  • 71336444
  • 71336446
  • 71336448
  • 71336450
  • 71336452
  • 71336454
  • 71336456
  • 71336458
  • 71336460
  • 71336462
  • 71336464
  • 71336466
  • 71336468"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BE. REFLECTION ACETABULAR SYSTEM - NO HOLE SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71334146
  • 71334148
  • 71334150
  • 71334152
  • 71334154
  • 71334156
  • 71334158
  • 71334160
  • 71334162
  • 71334164"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BF. REFLECTION ACETABULAR SYSTEM - HA COATED 3-HOLE SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71336246
  • 71336248
  • 71336250
  • 71336252
  • 71336254
  • 71336256
  • 71336258
  • 71336260
  • 71336262
  • 71336264"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BG.REFLECTION ACETABULAR SYSTEM - SCREW HOLE COVER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 71332500
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BH. REFLECTION ACETABULAR SYSTEM - SPIKED SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71336346
  • 71336348
  • 71336350
  • 71336352
  • 71336354
  • 71336356
  • 71336358
  • 71336360
  • 71336362
  • 71336364
  • 71336366
  • 71336368"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BI. REF. ACETABULAR SYS REF. 10 MRAD CROSS-LINKED POLYETHYLENE ACETAB. LINERS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71333301
  • 71333302
  • 71333303
  • 71333304
  • 71333306
  • 71333312
  • 71333313
  • 71333314
  • 71333315
  • 71333323
  • 71333324
  • 71333325
  • 71333326
  • 71333327
  • 71333328
  • 71333329
  • 71333334
  • 71333335
  • 71333336
  • 71333337
  • 71333338
  • 71333345
  • 71333346
  • 71333347
  • 71333348
  • 71333349
  • 71333350
  • 71333362
  • 71333363
  • 71333364
  • 71333373
  • 71333374
  • 71333375
  • 71333376
  • 71333377
  • 71333378
  • 71333379
  • 71333384
  • 71333385
  • 71333386
  • 71333387
  • 71333388
  • 71333389
  • 71333395
  • 71333396
  • 71333397
  • 71333398
  • 71333399
  • 71333412
  • 71333423
  • 71333424
  • 71333425
  • 71333426
  • 71333427
  • 71333428
  • 71333434
  • 71333435
  • 71333436
  • 71333437
  • 71333438
  • 71333445
  • 71333446
  • 71333447
  • 71333448
  • 71333449
  • 71333464
  • 71333473
  • 71333474
  • 71333475
  • 71333476
  • 71333477
  • 71333478
  • 71333484
  • 71333485
  • 71333486
  • 71333487
  • 71333488
  • 71333495
  • 71333496
  • 71333497"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BJ. REFLEC. ACETABULAR SYS REF. 10 MRAD CROSS-LINKED POLYETHYLENE ALL POLY CUPS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71358001
  • 71358002
  • 71358023
  • 71358025
  • 71358026
  • 71358027
  • 71358034
  • 71358035
  • 71358036
  • 71358037
  • 71358038
  • 71358039
  • 71358065
  • 71358066
  • 71358067"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BK. CPCS TOTAL HIP SYSTEM - COCR PRIMARY

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7131 2360
  • 7131 2361
  • 7131 2362
  • 7131 2363
  • 7131 2364
  • 7131 2365
  • 7131 2370
  • 7131 2371
  • 7131 2372
  • 7131 2373
  • 7131 2374
  • 7131 2375"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BL. REFLECTION CERAMIC HIP SYSTEM - REFLECTION FSO 5 ACETABULAR TI SHELLS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7133-9046
  • 7133-9048
  • 7133-9050
  • 7133-9052
  • 7133-9054
  • 7133-9056
  • 7133-9058
  • 7133-9060
  • 7133-9062
  • 7133-9064
  • 7133-9066"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BM. REFLECTION CERAMIC HIP SYSTEM - REFLECTION INTERFIT ACETABULAR SHELLS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7133-8046
  • 7133-8048
  • 7133-8050
  • 7133-8052
  • 7133-8054
  • 7133-8056
  • 7133-8058
  • 7133-8060
  • 7133-8062
  • 7133-8064
  • 7133-8066"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BN. REFLECTION CERAMIC HIP SYSTEM - ALUMINA INSERTS (28MM ID.) - CERAMIC

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7133-8146
  • 7133-8150
  • 7133-8156"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BO. REFLECTION CERAMIC HIP SYSTEM - ALUMINA INSERTS (32MM ID.) - CERAMIC

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7133-8250
  • 7133-8256"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BP. CPCS TOTAL HIP SYSTEM - SS PRIMARY

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7131 2381
  • 7131 2383
  • 7131 2392"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BQ.CPCS TOTAL HIP SYSTEM - SS FEMORAL HEAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71292800
  • 71292803
  • 71292804
  • 71293200
  • 71293203
  • 71293204
  • 71293208"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BR. ZIRCONIUM ALLOY OXINIUM FEMORAL HEAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71342200
  • 71342208
  • 71342212
  • 71342280
  • 71342284
  • 71342288
  • 71342320
  • 71342324
  • 71342328
  • 71342360
  • 71342364
  • 71342368
  • 71342600
  • 71342604
  • 71342608
  • 71342800
  • 71342803
  • 71342804
  • 71342808
  • 71342812
  • 71342816
  • 71343200
  • 71343203
  • 71343204
  • 71343208
  • 71343212
  • 71343216
  • 71343600
  • 71343603
  • 71343604
  • 71343608
  • 71343612"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BS. ECHELON HIP SYSTEM - POROUS PLUS HA STRAIGHT STEMS W/ COLLAR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71342011
  • 71342012
  • 71342013
  • 71342014
  • 71342015
  • 71342016
  • 71342017
  • 71342018
  • 71342019"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BT. ECHELON HIP SYSTEM - POROUS PLUS HA STRAIGHT STEMS W/ CALCAR COLLAR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71343011
  • 71343012
  • 71343013
  • 71343014
  • 71343015
  • 71343016
  • 71343017
  • 71343018
  • 71343019
  • 71343020"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BU. REFLECTION ACETABULAR SYSTEM - MULTI-HOLE SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71335150
  • 71335152
  • 71335154
  • 71335156
  • 71335158
  • 71335160
  • 71335162
  • 71335164
  • 71335166
  • 71335168"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BV.REFLECTION ACETABULAR SYSTEM - HA PERIPHERAL HOLE SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71335462
  • 71335464
  • 71335466
  • 71335468
  • 71335470
  • 71335472
  • 71335474
  • 71335476"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BW. SYNERGY HIP SYSTEM - HA COATED POROUS FEMORAL STEMS W/STANDARD OFFSET

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71309009
  • 71309010
  • 71309011
  • 71309012
  • 71309013
  • 71309014
  • 71309015
  • 71309016
  • 71309017
  • 71309018
  • 71309109
  • 71309110
  • 71309111
  • 71309112
  • 71309113
  • 71309114
  • 71309115
  • 71309116
  • 71309117
  • 71309118"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BX. COBALT CHROME FEMORAL HEAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71303600
  • 71303603
  • 71303604
  • 71303608
  • 71303612
  • 71322812
  • 71322816
  • 71323212
  • 71323216"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BY. OPTI-FIX HIP SYSTEM - OPTI-FIX LINER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7134-2244
  • 7134-2246
  • 7134-2646
  • 7134-2650
  • 7134-2656
  • 7134-2850
  • 7134-2856
  • 7134-3256
  • 7134-3263
  • 7192-7746"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

BZ. OPTI-FIX HIP SYSTEM - OPTI-FIX XLPE LINER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "7133-3580
  • 7133-3581
  • 7133-3583
  • 7133-3584
  • 7133-3586
  • 7133-3587"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CA. REFLECTION ACETABULAR SYSTEM - HA MULTI-HOLE SHELLS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71335250
  • 71335252
  • 71335254
  • 71335256
  • 71335258
  • 71335260
  • 71335262
  • 71335264
  • 71335266
  • 71335268"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CB. REFLECTION 3 ACETABULAR SYSTEM - MULTI-HOLE ACETABULAR SHELL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71338663
  • 71338664
  • 71338665
  • 71338666
  • 71338667
  • 71338668
  • 71338669
  • 71338671
  • 71338672
  • 71338673
  • 71338674
  • 71338675"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CC.OXINIUM MODULAR FEMORAL HEAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71342340
  • 71342344"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CD. COCR MODULAR FEMORAL HEAD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 71342640
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CE. SMF HIP STEM SYSTEM - STEM WITH STIKTITE STANDARD OFFSET

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71352510
  • 71352512
  • 71352700
  • 71352702
  • 71352704
  • 71352706"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CF. SMF HIP STEM SYSTEM - STEM WITH STIKTITE HIGH OFFSET

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71352511
  • 71352513
  • 71352701
  • 71352703
  • 71352705
  • 71352707
  • 71352709
  • 71352711"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CG. SMF HIP STEM SYSTEM - STEM WITH STIKTITE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71352501
  • 71352502
  • 71352503
  • 71352504
  • 71352505
  • 71352506
  • 71352507
  • 71352508"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CH. REDAPT REVISION FEMORAL SYSTEM PROXIMALLY FLUTED REVISION STEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71354313
  • 71354314
  • 71354315
  • 71354316
  • 71354317
  • 71354318
  • 71354319
  • 71354320
  • 71354321
  • 71354329
  • 71354330
  • 71354331
  • 71354332
  • 71354333
  • 71354334
  • 71354335
  • 71354339
  • 71354340"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CI. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVED REVISION

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71354360
  • 71354361
  • 71354362
  • 71354363
  • 71354364
  • 71354371
  • 71354384
  • 71354407
  • 71354409"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CJ. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVE STIKTITE W/ HA

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71354032
  • 71354033
  • 71354034
  • 71354036
  • 71354038
  • 71354042
  • 71354052"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CK. REDAPT REVISION FEMORAL SYSTEM MODULAR SLEEVE GRIT-BLASTED W/HA

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • "71354215
  • 71354217
  • 71354219"
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

CL. REDAPT SLEEVELESS MONOLITHIC REVISION STEM 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 71354763
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES

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