8 — Class II medical device recall Z-2359-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-08-19. The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragme
| Recall number | Z-2359-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-07-01 |
| Classified | 2015-08-10 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-08-26 |
| Quantity | 4,329 |
| Lot numbers | 20141, 20290, 20291, 20292, 20713, 21025, 21201, 21372, 21677, 21829, 21927, 22592, 22717, 22981, 23390, 23439, 23944, 24091, 24334, 24510, 24917, 24934, 25076, 25171, 25178, 4399543, 4411503, 4420609, 4425217, 4500163, 4500164, 4500686, 4516589, 4606034, 4606035, 4619636, 4631667, 4646360, 4658303, 4660046 and 75 more |
| Model numbers | 352.085 |
Product
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.
Reason for recall
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.
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-2359-2015. 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.