Recalls / —

—#122552

Product

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

FDA product code

GAD — Retractor

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Part # Lot # 325.01 1776332 325.01 1834589 325.01 1855361 325.01 1893067 325.01 1903596 325.01 1952258 325.01 1986932 325.01 3067805 325.01 3150691 325.01 3179456 325.01 3186865 325.01 3220973 325.01 3241083 325.01 3268079 325.01 3360992 325.01 3719234 325.01 3818913 325.01 4948929 325.01 4994679 325.01 4994680 325.01 5031083 325.01 5031085 325.01 5391773 325.01 5420979 325.01 5420980 325.01 5476369 325.01 5476370 325.01 5510070 325.01 5544585 325.01 5546329 325.01 5563699 325.01 5569041 325.01 5624246 325.01 5657366 325.01 5677289 325.01 5759764 325.01 5759765 325.01 5779363 325.01 7698954 325.01 7826103

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Synthes USA HQ, Inc.

Address

1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern

Worldwide Distribution - USA (Nationwide) and Canada.

Timeline

Recall initiated

2013-09-24

Posted by FDA

2013-11-18

Terminated

2015-06-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #122552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.