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

FDA device recall Z-2058-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

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.

Root cause

Packaging change control

Status

Terminated

Product code

HSB

Quantity affected

1,011,783

Distribution

Nationwide distribution.

Date initiated

2012-11-02

Date posted

2013-08-26

Date terminated

2016-09-27

Location

West Chester, PA

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