Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Fem

FDA device recall Z-0375-2016 · posted 2015-12-04 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

HSB

Quantity affected

5

Distribution

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

Date initiated

2015-11-02

Date posted

2015-12-04

Date terminated

2016-05-13

Location

West Chester, PA

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