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FDA device recall Z-0388-2014 · posted 2013-11-25 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.

Action taken

Synthes sent an Urgent: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. "Please remove this product from your inventory and return it to Synthes. A replacement product will be sent to you when available. If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) with the product to: " Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the document to Synthes by: Fax: 877-272-3517 "Email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or email Fieldaction@synthes.com We apologize for any inconvenience this may cause and thank you in advance for your attention and cooperation.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

369

Distribution

Nationwide Distribution.

Date initiated

2013-07-31

Date posted

2013-11-25

Date terminated

2015-06-01

Location

West Chester, PA