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Zimmer Sterile Packaged Implants (2017-03-09)
- 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
Affected Products
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
Reason
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.
Affected products
A. M/Dn Intramedullar Femoral Recon Nail
Lot or serial number
Tous les lots avant le 2027/03/01
Model or catalog number
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
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
B. Versys Hip Revision Femoral Stem Beaded
Lot or serial number
Before 2026/07 (All others)
Before 2027/03 (00784301508)
Model or catalog number
00784301508
00784301608
00784301708
00784301808
00784302008
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
C. ITST Fixation Femoral Nail
Lot or serial number
All before 2027/03/01
Model or catalog number
00-2257-480-04
00-2257-480-14
00-2257-500-04
00-2257-500-14
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
D. Zmr Hip Xl Porous Stem Nitrided Bowed
Lot or serial number
All before 2027/03/01
Model or catalog number
00-9921-240-33
00-9921-255-33
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
E. Segmental System Fluted Stem Extension Bowed
Lot or serial number
Before 2026/07 (All others)
Before 2026/09 (00585205417)
Before 2027/03 (00585205415)
Model or catalog number
00-5852-054-15
00-5852-054-16
00-5852-054-17
00-5852-054-18
00-5852-054-19
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
F. Segmental System Fluted Stem Ext Straight
Lot or serial number
All lots before 2027/03/01
Model or catalog number
00-5852-052-17
00-5852-052-18
00-5852-052-19
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
G. Segmental System Segment Male/Female Taper
Lot or serial number
All lots before 2027/03/01
Model or catalog number
00-5850-046-20
00-5850-046-22
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
H. Segmental System Variable Stiffness Stem Extension
Lot or serial number
All lots before 2027/03/01
Model or catalog number
00-5852-074-19
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES