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Zimmer Packaged Implants (2017-05-09)
- Starting date:
- May 9, 2017
- Posting date:
- June 1, 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-63428
Reason
Zimmer is initiating a field action for sterile-packaged implants packaged 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. Versa Fx Femoral Fixation Tube Plates
Lot or serial number
All lots expiring before May 2027
Model or catalog number
- 00-1193-130-16
- 00-1193-135-16
- 00-1193-135-18
- 00-1193-135-20
- 00-1193-140-16
- 00-1193-145-16
- 00-1193-150-16
- 00-1193-150-18
- 00-1193-150-20
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
B. Versa Fx Femoral Fixation Tube Plates
Lot or serial number
All lots expiring before May 2027
Model or catalog number
- 00-1193-090-16
- 00-1193-095-16
- 00-1193-095-18
- 00-1193-095-20
- 00-1193-095-22
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
C. M/Dn Intramedullary Fixation System
Lot or serial number
All lots expiring before May 2027
Model or catalog number
00-2240-010-48
00-2240-011-42
00-2240-011-44
00-2240-011-46
00-2240-011-48
00-2240-012-46
00-2240-012-48
00-2240-013-40
00-2240-013-42
00-2240-013-44
00-2240-013-46
00-2240-013-48
00-2240-014-34
00-2240-014-36
00-2240-014-38
00-2240-014-40
00-2240-014-42
00-2240-014-44
00-2240-014-46
00-2240-014-48
00-2252-300-15
00-2252-300-16
00-2252-320-14
00-2252-320-15
00-2252-320-16
00-2252-340-14
00-2252-340-15
00-2252-340-16
00-2252-360-14
00-2252-360-15
00-2252-380-14
00-2252-380-15
00-2252-400-11
00-2252-400-13
00-2252-400-14
00-2252-400-15
00-2252-420-11
00-2252-420-12
00-2252-420-13
00-2252-420-14
00-2252-420-15
00-2252-440-11
00-2252-440-12
00-2252-440-13
00-2252-440-14
00-2252-460-10
00-2252-460-11
00-2252-460-12
00-2252-460-13
00-2252-460-14
00-2252-480-10
00-2252-480-11
00-2252-480-12
00-2252-480-13
00-2252-480-14
00-2252-500-13
00-2252-500-14
00-2253-260-15
00-2253-280-15
00-2253-300-15
00-2253-320-14
00-2253-320-15
00-2253-340-14
00-2253-340-15
00-2253-360-14
00-2253-360-15
00-2253-380-14
00-2253-380-15
00-2253-400-13
00-2253-400-14
00-2253-400-15
00-2253-420-13
00-2253-420-14
00-2253-420-15
00-2253-440-11
00-2253-440-13
00-2253-440-14
00-2253-460-11
00-2253-460-12
00-2253-460-13
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
D. Itst Femoral Nails
Lot or serial number
All lots expiring before May 2027
Model or catalog number
00-2257-300-04
00-2257-300-14
00-2257-320-03
00-2257-320-04
00-2257-320-13
00-2257-320-14
00-2257-340-01
00-2257-340-03
00-2257-340-04
00-2257-340-11
00-2257-340-13
00-2257-340-14
00-2257-360-01
00-2257-360-02
00-2257-360-03
00-2257-360-04
00-2257-360-11
00-2257-360-12
00-2257-360-13
00-2257-360-14
00-2257-380-00
00-2257-380-01
00-2257-380-02
00-2257-380-03
00-2257-380-04
00-2257-380-10
00-2257-380-11
00-2257-380-12
00-2257-380-13
00-2257-380-14
00-2257-400-00
00-2257-400-01
00-2257-400-02
00-2257-400-03
00-2257-400-04
00-2257-400-10
00-2257-400-11
00-2257-400-12
00-2257-400-13
00-2257-400-14
00-2257-420-00
00-2257-420-01
00-2257-420-02
00-2257-420-03
00-2257-420-04
00-2257-420-10
00-2257-420-11
00-2257-420-12
00-2257-420-13
00-2257-420-14
00-2257-440-00
00-2257-440-01
00-2257-440-02
00-2257-440-03
00-2257-440-04
00-2257-440-10
00-2257-440-11
00-2257-440-12
00-2257-440-13
00-2257-440-14
00-2257-460-00
00-2257-460-01
00-2257-460-02
00-2257-460-03
00-2257-460-04
00-2257-460-10
00-2257-460-11
00-2257-460-12
00-2257-460-13
00-2257-460-14
00-2257-480-00
00-2257-480-01
00-2257-480-02
00-2257-480-03
00-2257-480-10
00-2257-480-11
00-2257-480-12
00-2257-480-13
00-2257-500-00
00-2257-500-01
00-2257-500-02
00-2257-500-03
00-2257-500-10
00-2257-500-11
00-2257-500-12
00-2257-500-13
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
E. Zimmer Natural Nail System Tibial Nails
Lot or serial number
All lots expiring before May 2027
Model or catalog number
47249538014
47249540014
47249542014
47249544014
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES
F. Zimmer Natural Nail System Femoral Nail
Lot or serial number
All lots expiring before May 2027
Model or catalog number
47-2492-460-14
47-2492-461-14
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
UNITED STATES