Z-1219-2015 Class II Terminated
FDA device recall Z-1219-2015 was initiated by Zimmer, Inc. on Feb 5, 2015 and is designated Class II. Reason for recall: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. The recall status is terminated (terminated Sep 23, 2015). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 11, 2015
- Initiation Date
- Feb 5, 2015
- Termination Date
- Sep 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Reason for Recall
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
Distribution Pattern
US Distribution to the state of TX
Code Information
Item No. 00-5852-052-10; Lot 62866438
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1219-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026