Device product
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Z-1219-2015
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 70500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1219-2015
Official wording
Reason: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Code information: Item No. 00-5852-052-10; Lot 62866438
Distribution pattern: US Distribution to the state of TX
Derived failure modes
-
Potency or specification failure
does not meet specifications