Zimmer Segmental Systems recall
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
Why was Zimmer Segmental Systems recalled?
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
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?
Part numbers 00-5850-013-95
- Product
- Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
- Recalling firm
- Zimmer, Inc.
- Quantity
- 5305 distribution events
- Distribution
- Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)