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

FDA device recall Z-1726-2013 · posted 2013-07-12 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQN

Quantity affected

10

Distribution

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

Date initiated

2013-06-12

Date posted

2013-07-12

Date terminated

2015-09-21

Location

West Chester, PA

Related 510(k) clearances