Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual Recalled by Synthes USA HQ, Inc. Due to Complaints were received for intraoperative reamer head breakages...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes USA HQ, Inc. directly.
Affected Products
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.
Quantity: 2979
Why Was This Recalled?
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes USA HQ, Inc.
Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report