FDA Device recall Z-0202-2014
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medic…
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medic… by Synthes Usa Hq, citing complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0202-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-03 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
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.
Reason
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Identifiers
| code_info | Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0202-2014%22
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