Recall Z-2483-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
| Date | Aug 29, 2015 (initiated Jul 28, 2015) |
| Status | Terminated |
| Reason | The device was assembled without screw hole plugs. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 5 |
| Distribution | Distributed in Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM Biomet, Inc., Apr 30, 2010 |