Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
FDA device recall Z-1123-2015 · posted 2015-02-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
- Action taken
- Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 17
- Distribution
- Distributed in the states of VA and TX and the country of Japan.
- Date initiated
- 2015-01-09
- Date posted
- 2015-02-17
- Date terminated
- 2015-10-22
- 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 |