Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.

FDA device recall Z-0452-2014 · posted 2013-12-05 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Action taken

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. 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 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return the Verification Frorm even if they do not have any of the affected product and return by fax to 1-888-386-2077 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Trauma Sales Consultant. For questions regarding this recall call 610-719-5000.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HSB

Quantity affected

17

Distribution

Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.

Date initiated

2013-07-30

Date posted

2013-12-05

Date terminated

2015-09-10

Location

West Chester, PA

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