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LCS COMPLETE KNEE SYSTEM (2015-03-05)
- Starting date:
- March 5, 2015
- Posting date:
- April 14, 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-52901
Recalled Products
A. LCS COMPLETE KNEE SYSTEM - RPS INSERT
B. LCS COMPLETE KNEE - RPS FLEXION FEMORAL
Reason
Depuy Orthopaedics Inc., is issuing a device correction for all lots of the LCS complete RPS Knee System and advising surgeons that the product labeling will be revised to include a warning that states the patella must be resurfaced when using this system. According to data from the Australian Orthopaedic Association National Joint Replacement Registry, failure to resurface the patella has been associated with a higher incidence of postoperative patello-femoral pain, potentially leading to a secondary procedure.
Affected products
A. LCS COMPLETE KNEE SYSTEM - RPS INSERT
Lot or serial number
All lots.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
DePuy Orthopaedics Inc.
700 Orthopaedics Drive, P.O. Box 988
Warsaw
46581-0988
Indiana
UNITED STATES
B. LCS COMPLETE KNEE - RPS FLEXION FEMORAL
Lot or serial number
All lots.
Model or catalog number
129411010
129411020
129411030
129411040
129411050
129411060
129411070
Companies
- Manufacturer
-
DePuy Orthopaedics Inc.
700 Orthopaedics Drive, P.O. Box 988
Warsaw
46581-0988
Indiana
UNITED STATES