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V40 AND PCA FEMORAL HEAD (2015-09-10)
- Starting date:
- September 10, 2015
- Posting date:
- September 29, 2015
- 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-55140
Recalled Products
- V40 FEMORAL HEAD
- L.F.I.T. V40 FEMORAL HEAD
- PCA FEMORAL HEAD
Reason
Stryker has received customer complaints for L.F.I.T V40 Vitallium Femoral Heads (manufactured July 7th 2014 - August 15th 2014). It was reported that the Femoral Head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. In each case a new v40 L.F.I.T Vitallium Femoral Head was opened and used.
Affected products
A. V40 FEMORAL HEAD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 6260-5-028
- 6260-5-032
- 6260-5-132
- 6260-5-232
- 6260-5-328
- 6260-5-332
- 6260-5-432
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
New Jersey
UNITED STATES
B. L.F.I.T. V40 FEMORAL HEAD
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 6260-9-028
- 6260-9-032
- 6260-9-132
- 6260-9-232
- 6260-9-328
- 6260-9-332
- 6260-9-428
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
New Jersey
UNITED STATES
C. PCA FEMORAL HEAD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 6280-0-128
- 6280-0-232
- 6280-0-332
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
New Jersey
UNITED STATES
- Date modified: