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DJO SURGICAL

Encore Medical, L.P. · Model 427-03-080 · UDI-DI 00888912080040

KWA KWZ LZO LPH

510(k) clearances

138,402

Adverse events (387 deaths)

203

Recalls

Facilities

Description

REVELATION HIP STEM 8.0 LT POROUS COATED W/P2

Recalls

Date	Firm	Reason
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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
2023-10-09	Biomet, 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.