Recall Z-2483-2015
Biomet, Inc. · initiated July 28, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
Codes / lots: Part Number:135250; Lot Number:946410
Reason for recall
The device was assembled without screw hole plugs.
FDA-determined cause: Under Investigation by firm
Action taken
Zimmer Biomet issued notices on July 28, 2015, via FedEx overnight mail and e-mail to customers. Customers were asked to return response forms and recalled devices to Zimmer Biomet. Customers with questions may call Seth Pixton, Field Action Specialist, at 574-372-1570, Monday through Friday from 8:00 am to 5:00 pm, or e-mail at: seth.pixton@zimmerbiomet.com.
Details
- Recall number
- Z-2483-2015
- Initiated
- July 28, 2015
- Posted by FDA
- August 29, 2015
- Terminated
- May 17, 2016
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Quantity
- 5
- Distribution
- Distributed in Canada and Japan.
- Recalling firm
- Biomet, Inc., Warsaw, IN