Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for

FDA device recall Z-0341-2014 · posted 2013-11-18 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened.

Action taken

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 31, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and immediately remove the affected lots from stock, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the letter by checking the appropriate box indicating affected product has been located and return the Verification Form with the product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have the identified product, they were instructed to complete the Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.e attached Verification Section and return to Synthes.

Root cause

Device Design

Status

Terminated

Product code

GAD

Quantity affected

374

Distribution

Worldwide Distribution - USA (Nationwide) and Canada.

Date initiated

2013-09-24

Date posted

2013-11-18

Date terminated

2015-06-01

Location

West Chester, PA