—#137950

Product

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K131548
Affected lot / code info: Part Number Lot Numbers 03.037.024 T102759

Why it was recalled

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

Root cause (FDA determination)

Process control

Action the firm took

A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2015-06-10
Posted by FDA: 2015-07-16
Terminated: 2016-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.