Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
FDA Recall Z-0375-2016 · Posted 2015-12-04
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Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-11-02
Date Terminated2016-05-13
Product Quantity5
Reason for Recall
TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
Firm Action
The firm, DePuy Synthes, sent an "URGENT NOTICE:MEDICAL DEVICE FIELD SAFETY NOTIFICATION" letter dated 11/2/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review the instructions listed in this notification; forward this notice to anyone in your customer's facility that needs to be informed; complete the attached Verification Section and send a copy of the completed Verification Section by: Fax: (866) 629-6186 or Scan/email: [email protected], if the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual, and maintain a copy of this notice.
If you have any questions, please call (610)719-5450.
Root Cause
Process control
Distribution Pattern
US Distribution to states of: CA, FL, MI and WI.
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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