Reported Aug 19, 2015 · Terminated
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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.
- Lot codes and dates
- Part Number 352.085
- Sold lot numbers
115 of 115 codes
439954344115034420609442521745001634500164450068645165894606034460603546196364631667464636046583034660046467633946911464691147470594947203514720352475791647692984769248479976647906464798484485618048828514899798491963449372554937251495670149566994977566499423950181615018284503415850341575050564505236550654335087496510205551020545124415512441651407145140716516106851852285203705522695852269595248981524927252492745249278
- Amount recalled
- 4329
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.
This product could cause temporary or reversible health problems — stop using it.
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