Home › PARCUS MEDICAL LLC › Twist AP Suture Anchors

Twist AP Suture Anchors

PARCUS MEDICAL LLC · Model 10927T · UDI-DI 00816342024945

MAI Prescription

510(k) clearances

17,071

Adverse events

Recalls

149

Facilities

Description

5.5mm Triple Twist Biocomposite

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.