Device product
Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Z-2571-2017
Product summary
- Event
- Event 76629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9867
- Official record key
device-enforcement:Z-2571-2017
Official wording
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Code information: Item Number: 00585205415, Lot Number Expiry Date Before: March 2027
Distribution pattern: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
Derived failure modes
-
Device software or design
design verification test failures