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Synthes CMF Distraction System recallZ-1726-2013 · Synthes USA HQ, Inc. · initiated Jun 12, 2013

Class II Terminated All recalls posted in July 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 firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.

FDA root cause category: Nonconforming Material/Component

What the company is doing

SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers did not have the affected product they were asked to complete the Verification Section and faxt to 610-251-9005. Customers with questions were instructed to call 610-719-5450 or e-mail [email protected]. For questions regarding this recall call 610-719-5450.

Recall details

Recall number
Z-1726-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 12, 2013
Posted by the FDA
Jul 12, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
10
Product code
MQN
FDA submissions
K060138
Distribution
Nationwide Distribution including PA, CT, DE, and NY.

Product description

Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

Code information (models, lots, serial numbers)

Part # 04.315.067 with lot #s 6184270 and/or 22612-04.

Other devices under the same FDA submission

9 devices cleared under K060138 — 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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