Fixone Biocomposite Anchor
AJU PHARM. CO., LTD. · Model KAB-47501ca · UDI-DI 08800039100786
Description
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.
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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