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HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD

Medos International Sàrl · Model 222459 · UDI-DI 10886705030873

MAI Prescription

510(k) clearances

17,493

Adverse events

Recalls

149

Facilities

Description

HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 6.5mm

Recalls

Date	Firm	Reason
2026-07-14	ConMed Corporation	Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17	Aju Pharm Co., Ltd.	Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2023-04-13	DePuy Mitek, Inc., a Johnson & Johnson Co.	IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be r

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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.