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Health product recall

Zimmer's various highly polished hip and knee implants(2017-12-07)

Starting date:
December 7, 2017
Posting date:
December 14, 2017
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-65426

Affected products

A. NEXGEN CKS LPS POROUS FEMORAL COMPONENT

B. NEXGEN CKS LPS-FLEX OPTION FEMORAL COMPONENT

C. NEXGEN CKS CR-FLEX GENDER SOLUTIONS FEMALE PRECOAT FEMORAL COMPONENT

D. NEXGEN CKS LPS-FLEX GENDER SOLUTIONS FEMALE OPTION FEMORAL COMPONENT

E. NEXGEN CKS CR PRECOAT FEMORAL COMPONENT

F. VERSYS HIP SYSTEM-REVISION FEMORAL STEM BEADED FULLCOAT

G. NEXGEN CKS LPS OPTION FEMORAL COMPONENT

H. NEXGEN CKS LEGACY KNEE CONSTRAINED CONDYLAR FEMORAL COMPONENT

I. CPT HIP SYSTEM-FEMORAL STEM NECK TAPER WITH CENTRALIZER

J. NEXGEN CKS CR-FLEX OPTION FEMORAL COMPONENT

K. NEXGEN CKS CR-FLEX POROUS FEMORAL COMPONENT

L. VERSYS HIP SYSTEM-REVISION FEMORAL STEM POROUS FULLCOAT BOWED

M. VERSYS HIP SYSTEM-FEMORAL STEM BEADED FULLCOAT PLUS

N. VERSYS HIP SYSTEM-FEMORAL STEM BEADED FULLCOAT PLUS LM

O. ZIMMER UNICOMPARTMENTAL KNEE SYSTEM HIGH FLEX PRECOAT FEMORAL COMPONENT

P. GENDER SOLUTIONS PATELLO-FEMORAL JOINT SYSTEM FEMORAL COMPONENT

Reason

Zimmer Biomet is conducting a medical device recall for various highly polished hip and knee implants that were packaged in a Low Density Polyethylene (LDPE) bag. The LDPE bag may become adhered to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. This recall is to remove additional lots not previously included in a similar recall initiated in January 2016

Affected products

A. NEXGEN CKS LPS POROUS FEMORAL COMPONENT

 

Lot or serial number

61782589

Model or catalog number

00-5992-016-02

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



B. NEXGEN CKS LPS-FLEX OPTION FEMORAL COMPONENT

 

Lot or serial number

More than 10 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



C. NEXGEN CKS CR-FLEX GENDER SOLUTIONS FEMALE PRECOAT FEMORAL COMPONENT

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

00-5750-013-01

00-5750-013-02

00-5750-013-06

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



D. NEXGEN CKS LPS-FLEX GENDER SOLUTIONS FEMALE OPTION FEMORAL COMPONENT

 

Lot or serial number

More than 10 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



E. NEXGEN CKS CR PRECOAT FEMORAL COMPONENT

 

Lot or serial number

11003323

61777581

61777583

Model or catalog number

00597001502

00597001602

00597001801

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



F. VERSYS HIP SYSTEM-REVISION FEMORAL STEM BEADED FULLCOAT

 

Lot or serial number

62085292

62097290

62120673

62184777

Model or catalog number

00784301336

00784301408

00784301736

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



G. NEXGEN CKS LPS OPTION FEMORAL COMPONENT

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

00599601351

00599601352

00599601451

00599601452

00599601551

00599601552

00599601651

00599601652

00599601751

00599601752

00599601851

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



H. NEXGEN CKS LEGACY KNEE CONSTRAINED CONDYLAR FEMORAL COMPONENT

 

Lot or serial number

61768099

61771826

Model or catalog number

00599401592

00599401691

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



I. CPT HIP SYSTEM-FEMORAL STEM NECK TAPER WITH CENTRALIZER

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

00811400000

00811400200

00811400210

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



J. NEXGEN CKS CR-FLEX OPTION FEMORAL COMPONENT

 

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

00-5956-013-01

00-5956-013-02

00-5956-013-06

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



K. NEXGEN CKS CR-FLEX POROUS FEMORAL COMPONENT

 

Lot or serial number

61782595

Model or catalog number

00-5952-016-01

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



L. VERSYS HIP SYSTEM-REVISION FEMORAL STEM POROUS FULLCOAT BOWED

 

Lot or serial number

61759260

61775246

61932605

61951276

Model or catalog number

00-7843-013-82

00-7843-015-82

00-7843-016-81

00-7843-016-82

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



M. VERSYS HIP SYSTEM-FEMORAL STEM BEADED FULLCOAT PLUS

 

Lot or serial number

61741806

Model or catalog number

00-7843-014-26

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



N. VERSYS HIP SYSTEM-FEMORAL STEM BEADED FULLCOAT PLUS LM

 

Lot or serial number

61987936

61993635

Model or catalog number

00-7843-013-56

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



O. ZIMMER UNICOMPARTMENTAL KNEE SYSTEM HIGH FLEX PRECOAT FEMORAL COMPONENT

 

Lot or serial number

61777613

61777616

61777617

Model or catalog number

00-5842-014-01

00-5842-014-02

00-5842-015-01

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



P. GENDER SOLUTIONS PATELLO-FEMORAL JOINT SYSTEM FEMORAL COMPONENT

Lot or serial number

61771794

61771796

61777452

Model or catalog number

00592601201

00592601301

00592601302

Companies
Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES


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