Stryker Orthopaedics Tibial Offset Bushing Triathlon recall
Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive…
Why was Stryker Orthopaedics Tibial Offset Bushing Triathlon recalled?
Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31
- Product
- Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 8
- Distribution
- Worldwide Distribution.
- Recall date
- December 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)