Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Slee
FDA device recall Z-0474-2013 · posted 2012-12-05 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
- Action taken
- Biomet, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 1, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The notification letter instructed the surgeon to montior the patient as their is a potential for increased wear which have an unknown effect on implant life. For questions call 574-372-1570.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWT
- Quantity affected
- 4
- Distribution
- USA Nationwide Distribution in the state of WI.
- Date initiated
- 2012-11-01
- Date posted
- 2012-12-05
- Date terminated
- 2013-08-29
- 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 |
|---|---|---|
| BIO-MODULAR SHOULDER SYSTEM (K030710) | Biomet, Inc. | 2003-06-04 |