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Titanium Trochanteric Fixation Nail (TFN)System recallZ-0452-2014 · Synthes USA HQ, Inc. · initiated Jul 30, 2013

Class II Terminated All recalls posted in December 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

Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return the Verification Frorm even if they do not have any of the affected product and return by fax to 1-888-386-2077 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Trauma Sales Consultant. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0452-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Dec 5, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
17
Product code
HSB
FDA submissions
K011857
Distribution
Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.

Product description

Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.

Code information (models, lots, serial numbers)

Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.

Other devices under the same FDA submission

44 devices cleared under K011857 — 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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