Tornier, Inc recalls Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument

Recall date

August 6, 2015

Source

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

Recall number

Z-2465-2015

FDA classification

Class II

Brand / firm

Tornier, Inc

Sold / distributed

Distributed to CA, ME, NC, PA, and TX.

Why it was recalled

Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide.

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

What was recalled

Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument