Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
FDA Recall Z-1352-2015 · Posted 2015-03-30
Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-02-24
Date Terminated2015-09-21
Product Quantity131
Reason for Recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Firm Action
DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.