Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of d

FDA device recall Z-1260-2015 · posted 2015-03-10 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.

Action taken

DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 3, 2015, to all affected customers to alert them about the recall and explain the benefits and risks associated with removing this device from the market. It stated that the immediate removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes is in the process of developing the replacement & recovery plan for indicated devices. Due to their current but temporary lack of replacement inventory, Synthes proposed to remove and replace the device in increments to prevent any adverse impact on the availability of the device for use on patients in trauma-related surgery events. DePuy Synthes will contact customers as replacements become available. Customers were advised to complete the Verification Section by checking the appropriate box indicating affected product has been located. Also,indicate the number of devices found. If your facility chooses to return the product(s) at this time, please take the following additional steps:Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, include a copy of Verification Section with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.Send the completed Verification Section to the following fax or email address: Fax: (866) 782-7287 or Scan/email: Synthes5095@stericycle.com Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 810-719-5000.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

1550

Distribution

Nationwide Distribution

Date initiated

2015-02-03

Date posted

2015-03-10

Date terminated

2016-08-26

Location

West Chester, PA