Taperloc Hip System (2019-09-19)

Starting date:
September 19, 2019
Posting date:
October 25, 2019
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-71351

Last updated:

Affected Products

  1. Taperloc Hip Standard Fem Stem
  2. Taperloc Hip Lateralized Fem Stem
  3. Ball Nose Guide Wire 3.0 MM x 80 CM
  4. Copeland Resurfacing Head
  5. DFS HA Cortical Tapered Screw
  6. Mallory-Head Hip Lateralized Fem Stem
  7. Compress Spindle
  8. Comprehensive RVS Baseplate
  9. Comprehensive RVS Mini Baseplate
  10. Ball Nose Guide Wire 3.0 MM x 100 CM
  11. Compress Anti-Rotation Spindle
  12. Compress Anti-Rotation Spindle
  13. Compress Short Anti-Rotation Spindle
  14. Compress Short Anti-Rotation Spindle - Elliptical
  15. Copeland EAS Resurfacing Head
  16. DFS HA Cortical Tapered Screw / DFS HA Cancellous Tapered Screw

Reason

A supplier who performs final cleaning operations on certain Zimmer Biomet products received an FDA warning letter earlier this year. Zimmer Biomet recently completed an assessment of that supplier following awareness of the warning letter. The assessment focused on devices processed prior to upgrades to the cleaning process, which began in March 2018.

The assessment identified that the clinical history of devices processed within that timeframe experienced expected performance, based on independent U.S. National Registry data and 57 global complaints for events associated with the identified risks from over 200,000 devices distributed. However, the supplier's associated quality standards at that time were not aligned with Zimmer Biomet's current quality standards. As a result, the previous cleaning process could result in elevated levels of bacterial endotoxin and residual debris remaining on the devices. While these elevated levels could result in a local tissue reaction, there is not an elevated risk of infection as the sterility of the devices is not impacted.

Out of an abundance of caution, Zimmer Biomet has made the decision to recall devices that were processed by this supplier and not further processed through the upgraded Zimmer Biomet cleaning. Devices processed by the upgraded cleaning process, and outside of the affected lot numbers, are not impacted by this action.

Affected products

A. Taperloc Hip Standard Fem Stem

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 21-103202
  • 21-103203
  • 21-103204
  • 21-103205
  • 21-103206
  • 21-103207
  • 21-103208
  • 21-103209
  • 21-103210
  • 21-103211
  • 21-103212
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

B. Taperloc Hip Lateralized Fem Stem

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 21-123202
  • 21-123203
  • 21-123204
  • 21-123205
  • 21-123206
  • 21-123207
  • 21-123208
  • 21-123209
  • 21-123210
  • 21-123211
  • 21-123212
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

C. Ball Nose Guide Wire 3.0 MM x 80 CM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2810-01-080

Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

D. Copeland Resurfacing Head

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 11-114641
  • 11-114642
  • 11-114643
  • 11-114644
  • 11-114645
  • 11-114646
  • 11-114647
  • 11-114648
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

E. DFS HA Cortical Tapered Screw

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

F. Mallory-Head Hip Lateralized Fem Stem

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • 21-124309
  • 21-124310
  • 21-124311
  • 21-124312
  • 21-124313
  • 21-124314
  • 21-124315
  • 21-124316
  • 21-124317
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

G. Compress Spindle

Lot or serial number
  • 52730
  • 103350
  • 228100
  • 234190
  • 859600
  • 920060
Model or catalog number
  • 178464
  • 178472
  • 178496
  • 178504
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

H. Comprehensive RVS Baseplate

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

115330

Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

I. Comprehensive RVS Mini Baseplate

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

10000589

Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

J. Ball Nose Guide Wire 3.0 MM x 100 CM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

2810-01-100

Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

K. Compress Anti-Rotation Spindle

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 178350
  • 178351
  • 178352
  • 178353
  • 178354
  • 178355
  • 178356
  • 178357
  • 178358
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

L. Compress Anti-Rotation Spindle

Lot or serial number
  • 114730
  • 282760
  • 311060
Model or catalog number
  • 178359
  • 178360
  • 178361
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

M. Compress Short Anti-Rotation Spindle

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 178362
  • 178363
  • 178364
  • 178365
  • 178366
  • 178367
  • 178368
  • 178369
  • 178370
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

N. Compress Short Anti-Rotation Spindle - Elliptical

Lot or serial number
  • 269860
  • 719220
  • 932080
Model or catalog number
  • 178371
  • 178372
  • 178373
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

O. Copeland EAS Resurfacing Head

Lot or serial number
  • 55720
  • 191740
  • 227710
  • 297880
  • 298670
  • 484850
  • 808640
  • 809740
Model or catalog number
  • 11-114662
  • 11-114663
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES

P. DFS HA Cortical Tapered Screw / DFS HA Cancellous Tapered Screw

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • HAA60-25040
  • HAB60-20080
Companies
Manufacturer
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES