Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083. The sys
FDA device recall Z-0360-2010 · posted 2010-05-12 · Terminated
Recall details
- Recalling firm
- Orthopediatrics Corp
- Reason for recall
- The potential exists for the nails to fracture during insertion of the nail.
- Action taken
- Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 23 of all products
- Distribution
- Nationwide.
- Date initiated
- 2009-07-21
- Date posted
- 2010-05-12
- Date terminated
- 2010-10-25
- 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 |
|---|---|---|
| PEDINAIL INTRAMEDULLARY NAILING SYSTEM (K083726) | OrthoPediatrics Corp. | 2009-03-11 |