FDA Device Intelligence
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CLS® Brevius™ Stem

Zimmer GmbH · Model 01.00296.060 · UDI-DI 00889024280618

KWAJDLJDIKWL Prescription
10
510(k) clearances
138,402
Adverse events (387 deaths)
203
Recalls
53
Facilities

Description

CLS Brevius Stem with Kinectiv, Size 6

Recalls

DateFirmReason
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
2023-10-09Biomet, Inc.Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

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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.