Synthes, Inc. recalls Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part…

Recall date

February 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1352-2015

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.