Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held devic

FDA device recall Z-0405-2014 · posted 2013-11-27 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

Action taken

Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 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 returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers were also instructed to return the Verification Section even if they don't have the affected product. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

LXH

Quantity affected

548

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada .

Date initiated

2013-10-08

Date posted

2013-11-27

Date terminated

2016-08-26

Location

West Chester, PA