Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
FDA device recall Z-2243-2013 · posted 2013-09-18 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
- Action taken
- A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HTY
- Quantity affected
- 1
- Distribution
- US distribution to MA.
- Date initiated
- 2013-04-18
- Date posted
- 2013-09-18
- Date terminated
- 2015-03-30
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM (K970733) | Synthes (Usa) | 1997-04-02 |