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Integra® MOVEMENT® Great Toe System

Ascension Orthopedics, Inc. · Model MGT89030PPH · UDI-DI 10381780116455

KWD Prescription

510(k) clearances

293

Adverse events

Recalls

Facilities

Description

The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.

Recalls

Date	Firm	Reason
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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
2022-02-01	BioPro, 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.