Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
FDA Recall Z-0474-2014 · Posted 2013-12-10
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2013-07-30
Date Terminated2015-09-10
Product Quantity12
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.
Firm Action
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: [email protected].
Customers with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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