—#141514

Product

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 product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K011857
Affected lot / code info: Part Number Lot Number 04.037.162S 7950511

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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: Synthes3826@stericycle.com, 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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Distribution to states of: CA, FL, MI and WI.

Timeline

Recall initiated: 2015-11-02
Posted by FDA: 2015-12-04
Terminated: 2016-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141514. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.