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Synthes Trauma Nail System. The devices are indication for… recallZ-2058-2013 · Synthes USA HQ, Inc. · initiated Nov 2, 2012

Class II Terminated All recalls posted in August 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Packaging change control

What the company is doing

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.

Recall details

Recall number
Z-2058-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 2, 2012
Posted by the FDA
Aug 26, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
1,011,783
Product code
HSB
FDA submissions
K011857, K033071, K033618, K040336, K040762
Distribution
Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

203 devices cleared under K011857, K033071, K033618, K040336, K040762 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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