—#119842

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.

FDA product code: MQN — External Mandibular Fixator And/Or Distractor
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K060138
Affected lot / code info: Part # 04.315.067 with lot #s 6184270 and/or 22612-04.

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 FieldAction@synthes.com. For questions regarding this recall call 610-719-5450.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution including PA, CT, DE, and NY.

Timeline

Recall initiated: 2013-06-12
Posted by FDA: 2013-07-12
Terminated: 2015-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.