Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

FDA device recall Z-0407-2014 · posted 2013-11-27 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Action taken

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.

Root cause

Pending

Status

Terminated

Product code

JDS

Quantity affected

14

Distribution

Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.

Date initiated

2013-07-30

Date posted

2013-11-27

Date terminated

2015-09-10

Location

West Chester, PA

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