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Synthes Titanium Cannulated Humeral Nail recallZ-0407-2014 · Synthes USA HQ, Inc. · initiated Jul 30, 2013

Class II Terminated All recalls posted in November 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

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

FDA root cause category: Pending

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 call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.

Recall details

Recall number
Z-0407-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Nov 27, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
14
Product code
JDS
FDA submissions
K033071
Distribution
Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.

Product description

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

Code information (models, lots, serial numbers)

Part # Lot #    04.001.620S 7115414  04.001.620S 7115417  04.001.620S 7115509  04.001.620S 7115510  04.001.622S 7115533  04.001.636S 7117902  04.001.636S 7117916  04.001.638S 7117924  04.001.640S 7119089  04.001.640S 7119107  04.001.642S 7117995  04.001.642S 7119125  04.001.644S 7117998  04.001.218S 7327816  04.001.444S 7379241  04.001.620s 7265517

Other devices under the same FDA submission

12 devices cleared under K033071 — 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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