Home › MPS Micro Precision Systems AG › Humeral IM reamer Ø6 x 341 mm, can. Ø2.3 mm, Big AO coup.
Humeral IM reamer Ø6 x 341 mm, can. Ø2.3 mm, Big AO coup.
MPS Micro Precision Systems AG · Model T4866 · UDI-DI 07640187911367
HTO
Prescription
10
510(k) clearances
29,419
Adverse events (5 deaths)
83
Recalls
355
Facilities
Description
Humeral monobloc intramedullary reamer is used to ream the medullary cavity of humeral bone prior to placing a nail. A range of diameter is proposed in regards with the nail to be implanted and a range of length is proposed in regards with the height of the bone. Different distal coupling are available to connect with existing power tool.This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-24 | Synthes (USA) Products LLC | Products not sterilized, sterility cannot be confirmed |
| 2022-12-07 | Zimmer, Inc. | Two planers were found to be unusable during sawbones shoulder training. |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
| 2020-11-19 | Synthes (USA) Products LLC | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniqu |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.