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Cannulated 1st MPJ Hemi Implant

VILEX LLC · Model CHI-4CH · UDI-DI 00841731106254

KWD Prescription
1
510(k) clearances
294
Adverse events
14
Recalls
49
Facilities

Description

Cannulated Hemi Implant #4 22x19 CoCr HA Coated

Recalls

DateFirmReason
2026-09-04restor3d Inc.Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha
2022-02-01BioPro, Inc.There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates tha

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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.