Synthes Trauma Nail System. The devices are indication for bone fixation.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- November 2, 2012
- Posted
- August 26, 2013
- Terminated
- September 27, 2016
- Recall Number
- Z-2058-2013
- Quantity
- 1,011,783
- Firm Location
- West Chester, PA
Reason for Recall
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.
Distribution
Nationwide distribution.
Lot / Code Info
Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897
Root Cause
Packaging change control
Action Taken
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.