FDA Device recall Z-2092-2015
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm)
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm) by Synthes, citing 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 be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2092-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-28 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
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
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 .
Identifiers
| code_info | Part numbers: 314.742 and 314.743; 314.745S and 314.746S; 352.250S-352.265S, all lot numbers:4345760 4521262 4546058…Part numbers: 314.742 and 314.743; 314.745S and 314.746S; 352.250S-352.265S, all lot numbers:4345760 4521262 4546058 4685596 4685599 5017013 5072316 5081823 5086873 5094929 5108268 5134954 5134970 5134981 5134985 5140579 5140580 5229647 5255450 5309787 5349578 5350424 5351419 5373244 5402084 5423190 5525258 5527721 5553375 5585914 5603891 5661544 5666966 5706536 6022147 6027929 6054082 6073843 6098786 6201377 6214406 6290254 6303124 6305043 6367680 6420957 6432477 6648785 7004945 7033360 7061003 7081940 7081941 7353279 7353280 7404016 7455951 7484549 15990-01 16442-01 4345755 4352274 4503423 4548807 4685603 4685604 4757748 4760853 5019101 5020041 5020042 5109277 5110260 5110261 5145363 5147873 5150052 5152434 5152576 5152577 5167593 5202031 5226297 5236556 5260781 5260782 5260783 5282283 5283188 5309788 5349601 5366405 5374205 5408910 5423185 5434205 5442581 5459053 5471386 5574677 558 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2092-2015%22
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