FDAFDA · Food and drugs·Recall number Z-0202-2014
Synthes 8.5 MM Medullary Reamer Product Usage: 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, bmT, 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.
Published November 20, 2013 · Recall initiated: October 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
- Lot
- Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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