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Terminated

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.

FDA Recall Z-2359-2015 · Posted 2015-08-10

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2015-07-01
Date Terminated2016-08-26
Product Quantity4329

Reason for Recall

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.

Firm Action

An urgent notice of medical device recall, dated July 1, 2015, was sent to end users and sales consultants to alert them about the device defect and potential risk to patients. Recipients were asked to complete the verification form and return it along with any affected devices their posession.

Root Cause

Other

Distribution Pattern

Worldwide Distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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