FDA Device Intelligence
HomeHPF SRL › ACETABULAR REAMER EVO 2 D58 mm

ACETABULAR REAMER EVO 2 D58 mm

HPF SRL · Model H0036555899 · UDI-DI 08057968716124

HWE
10
510(k) clearances
50,267
Adverse events (7 deaths)
101
Recalls
385
Facilities

Recalls

DateFirmReason
2018-09-19Encore Medical, LpManufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bi
2017-09-29The Anspach Effort, Inc.This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa
2017-05-22Zimmer Biomet, Inc.Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa

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.