Device product
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
Z-0784-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 66846
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5305 distribution events
- Official record key
device-enforcement:Z-0784-2014
Official wording
Reason: 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.
Code information: Part numbers 00-5850-013-95
Distribution pattern: Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
Derived failure modes
-
Unknown
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.