Recall Z-1219-2015
Zimmer, Inc. · initiated February 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
Codes / lots: Item No. 00-5852-052-10; Lot 62866438
Reason for recall
PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
FDA-determined cause: Process control
Action taken
Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. Locate and remove from inventory the affected products identified above. 3. Return any affected product with missing PMMA coating per the PER process 4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com. 5. Please notify Zimmer if the hospital that you have distributed the affected product to has implanted the product. In addition, identify the surgeons that have used this product. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Details
- Recall number
- Z-1219-2015
- Initiated
- February 5, 2015
- Posted by FDA
- February 27, 2015
- Terminated
- September 23, 2015
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Quantity
- 1 unit
- Distribution
- US Distribution to the state of TX
- Recalling firm
- Zimmer, Inc., Warsaw, IN