Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-2091-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 10, 2015

Date Posted: July 22, 2015

Recall Number: Z-2091-2015

Event ID: 71492

Reason for Recall:

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).

Status: Terminated

Product Quantity: 32

Code Information:

Part Number Lot Numbers 03.037.024 T102759

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated