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Health product recall

ZIMMER KNEE AND HIP SYSTEMS (2016-01-14)

Starting date:
January 14, 2016
Posting date:
February 2, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56896

Affected Products

  1. NEXGEN FEMORAL COMPONENT, LPS POROUS
  2. NEXGEN FEMORAL COMPONENT, LPS FLEX
  3. NEXGEN FEMORAL COMPONENT,LPS-FLEX ZIM.
  4. NEXGEN FEMORAL COMPONENT, CR-FLEX GSF
  5. NEXGEN FEMORAL COMP,LPS-FLEX GSF OPTION
  6. NEXGEN FEMORAL COMPONENT, LPS-FLEX POR.
  7. NEXGEN FEMORAL COMP,LPS-FLEX GSF
  8. NEXGEN FEMORAL COMP,CR-FLEX GSF POROUS
  9. NEXGEN FEMORAL COMPONENT, CR PRECOAT
  10. NEXGEN FEMORAL COMPONENT, CR POROUS
  11. VERSYS BEADED FULLCOAT REV.FEMORAL STEM
  12. NEXGEN FEMORAL COMP,POSTERIOR STABILIZE
  13. NEXGEN FEMORAL COMP,CONSTRAIN CONDYLAR
  14. CPT HIP SYSTEM, FEMORAL STEM NECK TAPER
  15. MULTIPOLAR BIPOLAR CUPS, METAL SHELL
  16. NEXGEN FEMORAL COMP, CR-FLEX PRECOAT
  17. NEXGEN FEMORAL COMP,CR-FLEX NO COATING
  18. NEXGEN FEMORAL COMPONENT,CR-FLEX POROUS
  19. CPT HIP SYSTEM, X-SMALL STEM
  20. CPT HIP SYSTEM, SMALL STEM
  21. VERSYS BEADED FULLCOAT PLUS,FEMORAL
  22. VERSYS BEADED FULLCOAT PLUS LM, STEM
  23. UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
  24. GENDER SOLUTIONS PATELLO-FEMORAL COMP.
  25. NEXGEN FEMORAL COMP, LPS-FLEX PRECOAT

Reason

In a follow-up correction, Zimmer Biomet is removing from the field a subset of highly polished implants that were packaged in a low density polyethylene (LDPE) bag with a potential to adhere to the implants. In September 2013, customers were asked to examine devices before use and return any showing signs of LDPE adhesion. At that time a new bag was introduced that resolves the issue and prevents the bag from adhering to the implants.

Affected products

A. NEXGEN FEMORAL COMPONENT, LPS POROUS

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5992-013-02
  • 00-5992-014-01
  • 00-5992-014-02
  • 00-5992-015-01
  • 00-5992-015-02
  • 00-5992-016-01
  • 00-5992-016-02
  • 00-5992-017-01
  • 00-5992-017-02
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

B. NEXGEN FEMORAL COMPONENT, LPS FLEX

Lot or serial number
  • 11004076
  • 61805199
  • 61838278
  • 61951346
  • 62061947
  • 77001359
  • 77001361
Model or catalog number
  • 00-5964-012-01
  • 00-5964-012-02
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

C. NEXGEN FEMORAL COMPONENT,LPS-FLEX ZIM.

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5964-013-51
  • 00-5964-013-52
  • 00-5964-014-51
  • 00-5964-014-52
  • 00-5964-015-51
  • 00-5964-015-52
  • 00-5964-016-51
  • 00-5964-016-52
  • 00-5964-017-51
  • 00-5964-017-52
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

D. NEXGEN FEMORAL COMPONENT, CR-FLEX GSF

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5750-013-01
  • 00-5750-013-02
  • 00-5750-014-01
  • 00-5750-014-02
  • 00-5750-014-05
  • 00-5750-014-06
  • 00-5750-015-01
  • 00-5750-015-02
  • 00-5750-015-05
  • 00-5750-015-06
  • 00-5750-016-01
  • 00-5750-016-02
  • 00-5750-016-05
  • 00-5750-016-06
  • 00-5750-017-01
  • 00-5750-017-02
  • 00-5750-017-05
  • 00-5750-017-06
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

E. NEXGEN FEMORAL COMP,LPS-FLEX GSF OPTION

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5764-013-51
  • 00-5764-013-52
  • 00-5764-014-51
  • 00-5764-014-52
  • 00-5764-015-51
  • 00-5764-015-52
  • 00-5764-016-51
  • 00-5764-016-52
  • 00-5764-017-51
  • 00-5764-017-52
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

F. NEXGEN FEMORAL COMPONENT, LPS-FLEX POR.

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5962-014-51
  • 00-5962-014-52
  • 00-5962-015-51
  • 00-5962-015-52
  • 00-5962-016-51
  • 00-5962-016-52
  • 00-5962-017-51
  • 00-5962-017-52
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

G. NEXGEN FEMORAL COMP,LPS-FLEX GSF

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 00-5762-014-51
  • 00-5762-014-52
  • 00-5762-015-51
  • 00-5762-015-52
  • 00-5762-016-51
  • 00-5762-016-52
  • 00-5762-017-51
  • 00-5762-017-52
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

H. NEXGEN FEMORAL COMP,CR-FLEX GSF POROUS

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5752-013-01
  • 00-5752-013-02
  • 00-5752-014-01
  • 00-5752-014-02
  • 00-5752-014-05
  • 00-5752-014-06
  • 00-5752-015-01
  • 00-5752-015-02
  • 00-5752-015-05
  • 00-5752-015-06
  • 00-5752-016-01
  • 00-5752-016-02
  • 00-5752-016-05
  • 00-5752-016-06
  • 00-5752-017-01
  • 00-5752-017-02
  • 00-5752-017-06
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

I. NEXGEN FEMORAL COMPONENT, CR PRECOAT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00597001102
  • 00597001301
  • 00597001401
  • 00597001402
  • 00597001501
  • 00597001502
  • 00597001601
  • 00597001602
  • 00597001701
  • 00597001702
  • 00597001801
  • 00597001802
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

J. NEXGEN FEMORAL COMPONENT, CR POROUS

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00597201301
  • 00597201302
  • 00597201401
  • 00597201402
  • 00597201501
  • 00597201502
  • 00597201601
  • 00597201602
  • 00597201701
  • 00597201702
  • 00597201801
  • 00597201802
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

K. VERSYS BEADED FULLCOAT REV.FEMORAL STEM

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00784301106
  • 00784301108
  • 00784301206
  • 00784301208
  • 00784301236
  • 00784301306
  • 00784301308
  • 00784301336
  • 00784301406
  • 00784301408
  • 00784301436
  • 00784301506
  • 00784301508
  • 00784301536
  • 00784301606
  • 00784301608
  • 00784301636
  • 00784301706
  • 00784301708
  • 00784301736
  • 00784301806
  • 00784301808
  • 00784301836
  • 00784302008
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

L. NEXGEN FEMORAL COMP, POSTERIOR STABILIZED

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00599601101
  • 00599601201
  • 00599601202
  • 00599601351
  • 00599601352
  • 00599601451
  • 00599601452
  • 00599601551
  • 00599601552
  • 00599601651
  • 00599601652
  • 00599601751
  • 00599601752
  • 00599601851
  • 00599601852
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

M. NEXGEN FEMORAL COMP,CONSTRAIN CONDYLAR

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00599401391
  • 00599401392
  • 00599401491
  • 00599401492
  • 00599401591
  • 00599401592
  • 00599401691
  • 00599401692
  • 00599401791
  • 00599401792
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

N. CPT HIP SYSTEM, FEMORAL STEM NECK TAPER

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00811400000
  • 00811400010
  • 00811400100
  • 00811400110
  • 00811400200
  • 00811400210
  • 00811400218
  • 00811400230
  • 00811400300
  • 00811400310
  • 00811400318
  • 00811400330
  • 00811400400
  • 00811400410
  • 00811400420
  • 00811400423
  • 00811400426
  • 00811400430
  • 00811400500
  • 00811400510
  • 00811400530
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

O. MULTIPOLAR BIPOLAR CUPS, METAL SHELL

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 5001-40
  • 5001-41
  • 5001-42
  • 5001-43
  • 5001-44
  • 5001-45
  • 5001-46
  • 5001-47
  • 5001-48
  • 5001-49
  • 5001-50
  • 5001-51
  • 5001-52
  • 5001-53
  • 5001-54
  • 5001-55
  • 5001-57
  • 5001-58
  • 5001-60
  • 5001-62
  • 5001-64
  • 5001-66
  • 5001-68
  • 5001-70
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

P. NEXGEN FEMORAL COMP, CR-FLEX PRECOAT

Lot or serial number
  • 61910866
  • 62064889
Model or catalog number
  • 00-5950-014-01
  • 00-5950-016-05
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

Q. NEXGEN FEMORAL COMP,CR-FLEX NO COATING

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5956-013-01
  • 00-5956-013-02
  • 00-5956-013-05
  • 00-5956-014-01
  • 00-5956-014-02
  • 00-5956-014-05
  • 00-5956-014-06
  • 00-5956-015-01
  • 00-5956-015-02
  • 00-5956-015-05
  • 00-5956-015-06
  • 00-5956-016-01
  • 00-5956-016-02
  • 00-5956-016-05
  • 00-5956-016-06
  • 00-5956-017-01
  • 00-5956-017-02
  • 00-5956-017-05
  • 00-5956-017-06
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

R. NEXGEN FEMORAL COMPONENT,CR-FLEX POROUS

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 5952-14-01
  • 5952-14-02
  • 5952-15-01
  • 5952-15-02
  • 5952-15-05
  • 5952-15-06
  • 5952-16-01
  • 5952-16-02
  • 5952-16-05
  • 5952-16-06
  • 5952-17-01
  • 5952-17-02
  • 5952-17-05
  • 5952-17-06
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

S. CPT HIP SYSTEM, X-SMALL STEM

Lot or serial number
  • 61878931
  • 61993208
  • 62106796
  • 62148557
Model or catalog number
  • 00811404000
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

T. CPT HIP SYSTEM, SMALL STEM

Lot or serial number
  • 61790499
  • 61891348
  • 61907682
  • 61993210
  • 62038367
  • 62161479
Model or catalog number
  • 00811405000
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

U. VERSYS BEADED FULLCOAT PLUS,FEMORAL

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 00-7843-011-26
  • 00-7843-012-26
  • 00-7843-013-26
  • 00-7843-014-26
  • 00-7843-015-26
  • 00-7843-016-26
  • 00-7843-017-26
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

V. VERSYS BEADED FULLCOAT PLUS LM, STEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 00-7843-012-56
  • 00-7843-013-56
  • 00-7843-014-56
  • 00-7843-015-56
  • 00-7843-016-56
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

W. UNICOMPARTMENTAL KNEE FEMORAL COMPONENT

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00-5842-011-01
  • 00-5842-011-02
  • 00-5842-012-01
  • 00-5842-012-02
  • 00-5842-013-01
  • 00-5842-013-02
  • 00-5842-014-01
  • 00-5842-014-02
  • 00-5842-015-01
  • 00-5842-015-02
  • 00-5842-016-01
  • 00-5842-016-02
  • 00-5842-017-01
  • 00-5842-017-02
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

X. GENDER SOLUTIONS PATELLO-FEMORAL COMP.

Lot or serial number

More than 100 numbers, contact manufacturer.

Model or catalog number
  • 00592601101
  • 00592601102
  • 00592601201
  • 00592601202
  • 00592601301
  • 00592601302
  • 00592601401
  • 00592601402
  • 00592601501
  • 00592601502
Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

Y. NEXGEN FEMORAL COMP, LPS-FLEX PRECOAT

Lot or serial number
  • 00-5960-018-51
  • 00-5960-018-52
Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

Date modified: