Synthes, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1352-2015)

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:

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

Product Classification:

Class II

Date Initiated: February 24, 2015

Date Posted: April 8, 2015

Recall Number: Z-1352-2015

Event ID: 70579

Reason for Recall:

The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.

Status: Terminated

Product Quantity: 131

Code Information:

Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563

Distribution Pattern:

US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA

Voluntary or Mandated:

Voluntary: Firm initiated