Oxford Unicompartmental Knee Phase 3 Shim recall
Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Why was Oxford Unicompartmental Knee Phase 3 Shim recalled?
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
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?
Item:32-420663, Lots: ZB160601, ZB160701
- Product
- Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Recalling firm
- Biomet U.K., Ltd.
- Quantity
- 72 units in total
- Distribution
- Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)