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Polaris 5.5 Spinal Fixation System

Highridge Medical, LLC · Model 2000-9092 · UDI-DI 03662663191968

HTO
10
510(k) clearances
29,419
Adverse events (5 deaths)
83
Recalls
355
Facilities

Description

5.5MM REAMER PROBE

Recalls

DateFirmReason
2024-01-24Synthes (USA) Products LLCProducts not sterilized, sterility cannot be confirmed
2022-12-07Zimmer, Inc.Two planers were found to be unusable during sawbones shoulder training.
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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
2020-11-19Synthes (USA) Products LLCRIA 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.