Reamer / Irrigator / Aspirator — Class II medical device recall Z-2092-2015
Terminated recall by Synthes, Inc., reported 2015-07-22, distributed nationwide. It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when inco
| Recall number | Z-2092-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-05-28 |
| Classified | 2015-07-16 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH |
| Quantity | 132,564 |
| Reason classes | device malfunction |
| Lot numbers | 15803-01, 15804-01, 15806-01, 15808-01, 15990-01, 16304-01, 16442-01, 16658-01, 4345755, 4345760, 4352274, 4503423, 4521262, 4546058, 4548807, 4685596, 4685599, 4685603, 4685604, 4726275, 4726276, 4728667, 4730095, 4730096, 4757748, 4760853, 4795727, 4795728, 4796513, 4796514, 4814913, 4814914, 4818231, 4819857, 4861250, 4865964, 4874043, 4874059, 4874060, 4874065 and 460 more |
| Model numbers | 314.742, 314.743 |
Product
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
Reason for recall
It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide .
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-2092-2015. 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.