Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
FDA Recall Z-0452-2014 · Posted 2013-12-05
Advertisement
Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2013-07-30
Date Terminated2015-09-10
Product Quantity17
Reason for Recall
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
Firm Action
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: [email protected].
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
Distribution Pattern
Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
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.
Advertisement