Synthes 8 — Class II medical device recall Z-0202-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-11-20, distributed nationwide. Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of
| Recall number | Z-0202-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-10-03 |
| Classified | 2013-11-12 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 2,979 |
| Lot numbers | 20141 |
| Model numbers | 352.085 |
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 for recall
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0202-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.