Home › MPS Micro Precision Systems AG › TRIGEN MAX IM REAMER HEAD 15 MM, FRONT CUTTING

TRIGEN MAX IM REAMER HEAD 15 MM, FRONT CUTTING

MPS Micro Precision Systems AG · Model T18770 · UDI-DI 07640187918038

HTO Prescription

510(k) clearances

29,528

Adverse events (5 deaths)

Recalls

358

Facilities

Description

Intramedullary reamer head is used in combination with the Intramedullary reamer shaft to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable.

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

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Data 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.