Synthes (USA) Products LLC recalls 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Uni…

Recall date

September 4, 2015

Source

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

Recall number

Z-0134-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Nationwide Distribution

Why it was recalled

This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).

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

What was recalled

5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.