Z-1726-2013Class II

Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or...

Name: Z-1726-2013 Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or...
Creator: Synthes USA HQ, Inc.
Published: 2013-06-12
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-06-12 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital... on 2013-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1726-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Posted: 2013-07-12
Terminated: 2015-09-21
Recalling firm: Synthes GmbH
Product: 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.
Product code: MQN External Mandibular Fixator And/Or Distractor
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 10
Distribution: Nationwide Distribution including PA, CT, DE, and NY.
Product codes and lots: Part # 04.315.067 with lot #s 6184270 and/or 22612-04.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1726-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1726-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-12

Product code MQN

K060138Class IISynthes (USA) Craniomaxillofacial Distraction SystemSynthes (Usa) / cleared 2006-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)