NexGen CompleteKnee Solution Stemmed Nonaugmentable recall: Particulate Matter
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The…
Why was NexGen CompleteKnee Solution Stemmed Nonaugmentable recalled?
Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset
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?
Catalog 00-5986-047-02, lots 62049114 and 62045235.
- Product
- NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 123 worldwide (33 USA)
- Distribution
- Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,
- Recall date
- December 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)