Recall Z-0094-2015
Zimmer, Inc. · initiated October 1, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Codes / lots: Part Number: 00-8757-068-02; Lot Number: 62207029
Reason for recall
The affected products are missing polar boss threads.
FDA-determined cause: Equipment maintenance
Action taken
Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, 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. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.
Details
- Recall number
- Z-0094-2015
- Initiated
- October 1, 2014
- Posted by FDA
- October 20, 2014
- Terminated
- March 2, 2015
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 19
- Distribution
- Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
- Recalling firm
- Zimmer, Inc., Warsaw, IN