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Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI… recallZ-0375-2016 · Synthes (USA) Products LLC · initiated Nov 2, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0375-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 2, 2015
Posted by the FDA
Dec 4, 2015
Recalling firm
Synthes (USA) Products LLC
Quantity
5
Product code
HSB
FDA submissions
K011857
Distribution
US Distribution to states of: CA, FL, MI and WI.

Product description

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.

Code information (models, lots, serial numbers)

Part Number Lot Number 04.037.162S 7950511

Other devices under the same FDA submission

44 devices cleared under K011857 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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