2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Ma

FDA device recall Z-1021-2015 · posted 2015-01-28 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.

Action taken

An Urgent Notice: Medical Device Recall, dated December 19, 2014, was sent to end users and sales consultants that described the product, problem, and action to be taken. End users/sales staff were requested to immediately stop use and remove affected product from inventory. Customers were asked to call and obtain a Return Authorization Number, and complete and return the Verification Section of the letter along with the devices to Synthes per the instructions provided. Questions should be directed to 610-719-5450 or your local DePuy Synthes sales consultant.

Root cause

Finished device change control

Status

Terminated

Product code

HXW

Quantity affected

973

Distribution

Worldwide Distribution -- US and Canada.

Date initiated

2014-12-15

Date posted

2015-01-28

Date terminated

2016-08-18

Location

West Chester, PA