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VEGA

OSTEONIC CO.,Ltd. · Model CIS0823-BC · UDI-DI 08800071020875

MAI
1
510(k) clearances
17,071
Adverse events
97
Recalls
149
Facilities

Recalls

DateFirmReason
2026-07-14ConMed CorporationSuture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2025-12-17Aju Pharm Co., Ltd.Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
2023-04-13DePuy 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.