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RIGIDFIX

DEPUY MITEK, LLC · Model 210333 · UDI-DI 10886705000920

MAI HWC JDR HTY MBI Prescription

510(k) clearances

17,237

Adverse events

Recalls

149

Facilities

Description

RIGIDFIX TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Absorbable Poly Lactic Acid (PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar

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.