FDA Device Intelligence
Home › PB SWISS TOOLS AG › OPERACE

OPERACE

PB SWISS TOOLS AG · Model 80015 · UDI-DI 07610733850150

HTO Prescription
10
510(k) clearances
29,528
Adverse events (5 deaths)
83
Recalls
358
Facilities

Description

Sterile single use insert for the removal of screws with seperated screw head or broken screws

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

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 docs
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.