Zimmer Sterile Packaged Implants (2017-03-09)

Zimmer Sterile Packaged Implants (2017-03-09) - Recalls and safety alerts
Starting date:
March 9, 2017
Posting date:
March 24, 2017
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-62780

A. M/Dn Intramedullar Femoral Recon Nail
B. Versys Hip Revision Femoral Stem Beaded
C. ITST Fixation Femoral Nail
D. Zmr Hip Xl Porous Stem Nitrided Bowed
E. Segmental System Fluted Stem Extension Bowed
F. Segmental System Fluted Stem Ext Straight
G. Segmental System Segment Male/Female Taper
H. Segmental System Variable Stiffness Stem Extension

Zimmer is initiating a field action for sterile-packaged implants in two different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the two configurations failed simulated distribution and shipping testing. The devices impacted are generally the heaviest outlier sizes within the respective product family.

 

Tous les lots avant le 2027/03/01

00-2252-360-16
00-2252-380-16
00-2252-400-16
00-2252-420-16
00-2252-440-15
00-2252-440-16
00-2252-460-15
00-2252-460-16
00-2252-480-15
00-2252-480-16
00-2252-500-15
00-2252-500-16
00-2253-440-15

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

Before 2026/07 (All others)
Before 2027/03 (00784301508)

00784301508
00784301608
00784301708
00784301808
00784302008

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

All before 2027/03/01

00-2257-480-04
00-2257-480-14
00-2257-500-04
00-2257-500-14

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

All before 2027/03/01

00-9921-240-33
00-9921-255-33

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

Before 2026/07 (All others)
Before 2026/09 (00585205417)
Before 2027/03 (00585205415)

00-5852-054-15
00-5852-054-16
00-5852-054-17
00-5852-054-18
00-5852-054-19

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

All lots before 2027/03/01

00-5852-052-17
00-5852-052-18
00-5852-052-19

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

All lots before 2027/03/01

00-5850-046-20
00-5850-046-22

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

 

 

All lots before 2027/03/01

00-5852-074-19

Manufacturer

Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES

Did you like this article?