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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

  1. V40 FEMORAL HEAD
  2. L.F.I.T. V40 FEMORAL HEAD
  3. 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