Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is inten

FDA device recall Z-0474-2014 · posted 2013-12-10 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

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 take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Root cause

Employee error

Status

Terminated

Product code

HSB

Quantity affected

12

Distribution

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Date initiated

2013-07-30

Date posted

2013-12-10

Date terminated

2015-09-10

Location

West Chester, PA

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