Recall Z-2058-2013 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
Synthes Trauma Nail System. The devices are indication for bone fixation.
| Date | Aug 26, 2013 (initiated Nov 2, 2012) |
| Status | Terminated |
| Reason | Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. |
| Root cause | Packaging change control |
| Action | The firm initiated their recall of this product on November 2, 2012 by sending an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter to all consignees. The letter explained the problem and gave instructions for consignees to examine their inventory and urged consignees to return the identified devices. The letter stated If returning the product would adversely impact their ability to provide necessary medical care to patients, they should re-sterilize the product per Pre-Vacuum Sterilization instructions contained in the Instruction for Use. |
| Quantity | 1,011,783 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011857 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM Synthes (Usa), Sep 12, 2001 |
| K033071 | SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM Synthes (Usa), Nov 5, 2003 |
| K033618 | SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM Synthes (Usa), Feb 5, 2004 |
| K040336 | SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM Synthes (Usa), Apr 12, 2004 |
| K040762 | SYNTHES (USA) TIBIAL NAIL SYSTEM EX Synthes (Usa), Apr 12, 2004 |