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

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

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

 

61782589

00-5992-016-02

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

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

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

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

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

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

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

11003323
61777581
61777583

00597001502
00597001602
00597001801

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

62085292
62097290
62120673
62184777

00784301336
00784301408
00784301736

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

00599601351
00599601352
00599601451
00599601452
00599601551
00599601552
00599601651
00599601652
00599601751
00599601752
00599601851

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61768099
61771826

00599401592
00599401691

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

00811400000
00811400200
00811400210

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

More than 10 numbers, contact manufacturer.

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

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61782595

00-5952-016-01

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61759260
61775246
61932605
61951276

00-7843-013-82
00-7843-015-82
00-7843-016-81
00-7843-016-82

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61741806

00-7843-014-26

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61987936
61993635

00-7843-013-56

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61777613
61777616
61777617

00-5842-014-01
00-5842-014-02
00-5842-015-01

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

61771794
61771796
61777452

00592601201
00592601301
00592601302

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

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