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IM reamer head dove tail Ø11.5 x 25 mm, can. Ø3.4 mm

MPS Micro Precision Systems AG · Model T3297 · UDI-DI 07640187911077

HTO Prescription

510(k) clearances

29,419

Adverse events (5 deaths)

Recalls

355

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. A range of diameter is proposed in regards with the nail to be implanted. Different coupling are available to connect the shaft with existing power tool. 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.