—#119782

Product

Synthes Trauma Nail System. The devices are indication for bone fixation.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K011857, K033071, K033618, K040336, K040762
Affected 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

Why it was recalled

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 (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2012-11-02
Posted by FDA: 2013-08-26
Terminated: 2016-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.