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Fix2Lock
OSTEONIC CO.,Ltd. · Model BHA-5320-2190 · UDI-DI 08809595976545
1
510(k) clearances
17,071
Adverse events
97
Recalls
149
Facilities
Description
Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(USP#2)(White/Blue 1, Blue 1)
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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Get your free API keyRead the docsData 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.