Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
FDA device recall Z-2483-2015 · posted 2015-08-29 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The device was assembled without screw hole plugs.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 5
- Distribution
- Distributed in Canada and Japan.
- Date initiated
- 2015-07-28
- Date posted
- 2015-08-29
- Date terminated
- 2016-05-17
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RINGLOC + HYBRID ACETABULAR SYSTEM (K093235) | Biomet, Inc. | 2010-04-30 |