Synthes (USA) Products LLC recalls 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered…

Recall date

July 1, 2015

Source

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

Recall number

Z-2359-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Worldwide Distribution.

Why it was recalled

The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

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

What was recalled

8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.