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Synthes Trochanteric Fixation Nail recallZ-0474-2014 · 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

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

FDA root cause category: Employee error

What the company is doing

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0474-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Dec 10, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
12
Product code
HSB
FDA submissions
K011857
Distribution
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Product description

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Code information (models, lots, serial numbers)

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

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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