NexGen¿ Complete Knee Solutions Stemmed Tibial recall
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained…
Why was NexGen¿ Complete Knee Solutions Stemmed Tibial recalled?
Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010 .
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?
00-5980-037-02; lot 6228417
- Product
- NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 128 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.
- Recall date
- December 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)