OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended fo
FDA device recall Z-0417-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).
- Action taken
- Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 3 units & 1 pending release
- Distribution
- Distributed only in The Netherlands.
- Date initiated
- 2011-11-01
- Date posted
- 2012-01-11
- Date terminated
- 2012-09-10
- 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 |
|---|---|---|
| ONCOLOGY SALVAGE SYSTEM (K002757) | Biomet, Inc. | 2000-11-24 |