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Various Medical Devices Recalled by Biomet 3i (2015-11-30), Part 2

Starting date:
November 30, 2015
Posting date:
January 29, 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-56660

Affected Products

  • Bh. DAL-RO HOUSING THREADED FEMALE
  • Bi. DAL-RO HOUSING/FEMALE ASSEMBLY
  • Bj. LOCATOR REPLACEMENT HOUSING
  • Bk. CERTAIN MICROMINIPLANT PERFORMANCE POST
  • Bl. CERTAIN MICROMINIPLANT PREFORMANE PRE-ANGLED POST
  • Bm. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CYLINDER
  • Bn. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
  • Bo. LOCATOR EXTRA LIGHT ANGLE REPLACEMENT MALE
  • Bp. PREFORMANCE POST
  • Bq. PREFORMANCE PRE-ANGLED POST
  • Br. MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
  • Bs. PREFORMANCE TEMPORARY CYLINDER
  • Bt. MICROMINIPLANT LOCATOR ABUTMENT
  • Bu. CERTAIN MICROMINIPLANT LOCATOR ABUTMENT
  • Bv. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
  • Bw. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
  • Bx. WIDE DIAMETER 5.0MM EP ONE-PIECE HEALING ABUTMENT
  • By. LOCATOR ABUTMENT
  • Bz. LOCATOR ABUTMENT IMPRESSION COPING
  • Ca. LOCATOR REPLACEMENT MALES
  • Cb. GINGIHUE 15 DEGREE PRE-ANGLED POST
  • Cc. STA ABUTMENTS - STANDARD ABUTMENT
  • Cd. STA ABUTMENTS-MICROMINIPLANT GINGIHUE POST
  • Ce. STA ABUTMENTS-CONICAL ABUTMENT GOLD STANDARD
  • Cf. STA ABUTMENTS-CONICAL ABUTMENT
  • Cg. STA ABUTMENTS-GINGIHUE POST W/SLA
  • Ch. GINGIHUE PRE-ANGLED POST
  • Ci. STA ABUTMENTS-STANDARD ABUTMENT
  • Cj. STA ABUTMENTS-CERTAIN CONICAL ABUTMENT
  • Ck. CERTAIN LOCATOR ABUTMENTS
  • Cl. CERTAIN HEALING ABUTMENT
  • Cm. WIDE DIAMETER ONE-PIECE CERTAIN HEALING ABUTMENT
  • Cn. ONE-PIECE CERTAIN MICROMINIPLANT HEALING ABUTMENT
  • Co. CERTAIN GOLD-TITE HEXED LARGE DIAMETER SCREW
  • Cp. GOLD-TITE SQUARE UNISCREW
  • Cq. GOLD-TITE HEXED RETAINING SCREW
  • Cr. LOCATOR LIGHT RETENTION MALES
  • Cs. LOCATOR EXTENDED RANGE MALES
  • Ct. CERTAIN GINGIHUE POST (ABUTMENT)
  • Cu. CERTAIN EP HEALING ABUTMENT

Reason

During the investigation of a customer complaint, two packages of LOCATOR Abutments (LOA002) were confirmed to have not been sealed during manufacturing.

Affected products

Bh. DAL-RO HOUSING THREADED FEMALE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

DRAF

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bi. DAL-RO HOUSING/FEMALE ASSEMBLY

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

DRTH

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bj. LOCATOR REPLACEMENT HOUSING

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LOAH                                                                                        LORHK

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bk. CERTAIN MICROMINIPLANT PERFORMANCE POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMPFP34
IMPFP354
IMPFP356
IMPFP36
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bl. CERTAIN MICROMINIPLANT PREFORMANE PRE-ANGLED POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMPAPF354
IMPAPF356
IMPAPF36
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bm.  CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CYLINDER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMPFTC32
IMPFTC34
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bn. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IPFP456
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bo. LOCATOR EXTRA LIGHT ANGLE REPLACEMENT MALE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LAELM                                                                                     LELARM

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bp. PREFORMANCE POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PFP454
PFP456
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bq. PREFORMANCE PRE-ANGLED POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PAPF454
PAPF456
PAPF554
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Br. MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MPFTC32
MPFTC34
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bs. PREFORMANCE TEMPORARY CYLINDER

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bt. MICROMINIPLANT LOCATOR ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MLOA001
MLOA002
MLOA003
MLOA004
MLOA005
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bu. CERTAIN MICROMINIPLANT LOCATOR ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMLOA001
IMLOA002
IMLOA003
IMLOA004
IMLOA005
IMLOA006
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bv. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

AC4217
AC4225
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bw. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IAC4217
IAC4225
IAC4417
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bx. WIDE DIAMETER 5.0MM EP ONE-PIECE HEALING ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

By. LOCATOR ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LOA001
LOA002
LOA003
LOA004
LOA005
LOA006
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Bz. LOCATOR ABUTMENT IMPRESSION COPING

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LAIC1

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Ca. LOCATOR REPLACEMENT MALES

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LARMS

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cb. GINGIHUE 15 DEGREE PRE-ANGLED POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

PAP454G
PAP462G
PAP552G
PAP554G
PAP562G

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cc. STA ABUTMENTS - STANDARD ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

AB200

AB300

AB400

AB550

AB700 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cc. STA ABUTMENTS-MICROMINIPLANT GINGIHUE POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MPAP32G

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cd. STA ABUTMENTS-CONICAL ABUTMENT GOLD STANDARD

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SCA004

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cf.  STA ABUTMENTS-CONICAL ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CA002
CA004

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cg. STA ABUTMENTS-GINGIHUE POST W/SLA

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

GSH20
GSH30
GSH7

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Ch. GINGIHUE PRE-ANGLED POST

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Ci. STA ABUTMENTS-STANDARD ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IAB200
IAB300
IAB400
IAB550

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cj. STA ABUTMENTS-CERTAIN CONICAL ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

ICA001                                                                                          ICA002                                                                                          ICA003                                                                                                ICA004

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Ck. CERTAIN LOCATOR ABUTMENTS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

ILOA001
ILOA002
ILOA003
ILOA004
ILOA005
ILOA006
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cl. CERTAIN HEALING ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cm. WIDE DIAMETER ONE-PIECE CERTAIN HEALING ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cn. ONE-PIECE CERTAIN MICROMINIPLANT HEALING ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

ISMHA32
ISMHA33
ISMHA34
ISMHA36

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Co. CERTAIN GOLD-TITE HEXED LARGE DIAMETER SCREW

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

ILRGHG

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cp. GOLD-TITE SQUARE UNISCREW

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

UNISG
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cq. GOLD-TITE HEXED RETAINING SCREW

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

THA42                                                                                               THA43                                                                                         THA44
THA46

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cr. LOCATOR LIGHT RETENTION MALES

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LLRMS
 

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cs. LOCATOR EXTENDED RANGE MALES

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

LAERM

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Ct. CERTAIN GINGIHUE POST (ABUTMENT)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMPAP352G                                                                      IMPAP354G

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES

Cu. CERTAIN EP HEALING ABUTMENT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

IMHA352                                                                                    IMHA353                                                                                         IMHA354                                                                                           IMHA356

Companies
Manufacturer
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES