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Versys Beaded Fullcoat Stem - Standard,Offset and Stem-Offset (LM) (2014-06-03)
- Starting date:
- June 3, 2014
- Posting date:
- June 19, 2014
- 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-40063
Recalled Products
A) Versys Beaded Fullcoat Stem - Standard
B) Versys Beaded Fullcoat Stem - Offset
C) Versys Beaded Fullcoat Stem-Offset (LM)
Reason
Zimmer is initiating a recall of four (4) lots of various configurations of the Versys Beaded Fullcoat Stems in Canada because the devices could be composed of nonconforming material. The raw material supplier commingled low-carbon cobalt-chrome alloy into one specific heat treated lot of high-carbon cobalt-chrome alloy. These beaded hip stem forgings did not meet material requirements.
Affected products
A) Versys Beaded Fullcoat Stem - Standard
Lot or serial number
62554362
Model or catalog number
00784301208
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES
B) Versys Beaded Fullcoat Stem - Offset
Lot or serial number
62496464
Model or catalog number
00-7843-013-26
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES
C) Versys Beaded Fullcoat Stem-Offset (LM)
Lot or serial number
62489572
62522386
Model or catalog number
00-7843-012-56
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES