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Health product recall

Nexgen Femoral Component (2013-09-05)

Starting date:
September 5, 2013
Posting date:
September 27, 2013
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-35931

Recalled 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 Component, LPS-Flex GSF
  6. Nexgen Femoral Component, LPS-Flex Por.
  7. Nexgen Femoral Comp,LPS-Flex GSF Porous
  8. Nexgen Femoral Comp,CR-Flex GSF Porous
  9. Nexgen Femoral Component, CR Precoat
  10. Nexgen Femoral Component, CR Porous
  11. Versys Beaded Fullcoat Femoral Stem +
  12. Nexgen Femoral Component, LPS Option
  13. Nexgen Femoral Component, LCCK Option
  14. CPT Femoral Stem
  15. Multipolar Bipolar Cup
  16. Nexgen Femoral Comp, CR-Flex Precoat
  17. Nexgen Femoral Component,CR-Flex Option
  18. Nexgen Femoral Component,CR-Flex Porous
  19. CPT Femoral Stem, Extra Small
  20. CPT Femoral Stem, Small
  21. Versys Beaded Fullcoat Femoral Stem Std.
  22. Versys Beaded Fullcoat Femoral Stem, LM
  23. Unicompartmental Knee Femoral Component
  24. Gender Solutions Patello-Femoral Comp.
  25. Nexgen Femoral Comp, LPS-Flex Precoat

Reason

Zimmer is initiating a recall of a subset of variously highly polished implants packaged in low density polyethylene (LDPE) bag because Zimmer has received complaints that the LDPE bag containing the implant adheres to the highly polished implant surface. The level of adhesion can vary, resulting in material transfer to the implants that can range from residue to pieces of film from the LDPE bag.

Affected products

A. Nexgen Femoral Component, LPS Porous

 

Lot or serial number

More than 10 serial 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

Indiana

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

Indiana

UNITED STATES



C. Nexgen Femoral Component, LPS-Flex Zim.

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



D. Nexgen Femoral Component, CR-Flex GSF

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



E. Nexgen Femoral Component, LPS-Flex GSF

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



F. Nexgen Femoral Component, LPS-Flex Por.

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



G. Nexgen Femoral Comp,LPS-Flex GSF Porous

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



H. Nexgen Femoral Comp,CR-Flex GSF Porous

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer 

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



I.  Nexgen Femoral Component, CR Precoat

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



J. Nexgen Femoral Component, CR Porous

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



K. Versys Beaded Fullcoat Femoral Stem +

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



L. Nexgen Femoral Component, LPS Option

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



M. Nexgen Femoral Component, LCCK Option

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



N. CPT Femoral Stem

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



O. Multipolar Bipolar Cup

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

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

Indiana

UNITED STATES



Q. Nexgen Femoral Component,CR-Flex Option

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



R. Nexgen Femoral Component,CR-Flex Porous

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



S. CPT Femoral Stem, Extra Small

 

Lot or serial number
  • 61878931
  • 61993208
  • 62106796
  • 62148557
Model or catalog number
  • 00811404000
Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



T.  CPT Femoral Stem, Small

 

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

Indiana

UNITED STATES



U. Versys Beaded Fullcoat Femoral Stem Std.

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



V. Versys Beaded Fullcoat Femoral Stem, LM

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



W. Unicompartmental Knee Femoral Component

 

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number

More than 10 serial numbers, contact manufacturer

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES



X. Gender Solutions Patello-Femoral Comp.

 

Lot or serial number

More than 10 serial 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

Indiana

UNITED STATES



Y. Nexgen Femoral Comp, LPS-Flex Precoat

Lot or serial number

More than 10 serial numbers, contact manufacturer

Model or catalog number
  • 00-5960-018-51
  • 00-5960-018-52
Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

Indiana

UNITED STATES


Date modified: