Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor and 7 more products

Aju Pharm Co., Ltd. is recalling Fixone Hybrid Anchor and seven related suture anchor products (Fixone Biocomposite Anchor; Genesis Screw‑In, Dual Thread Screw‑In, Knotless, and Push‑In Suture Anchors; AlternatiV+ Max Knotless and AlternatiV+ Screw‑In Anchors) sold in the United States (CA and PR) and identified by the listed model numbers, all UDI codes, and all lots. The recall follows reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

What's being recalled

Fixone Hybrid Anchor

Fixone Biocomposite Anchor

Genesis Screw-In Anchor

Genesis Dual Thread Screw-In Anchor

Genesis Knotless Anchor

Genesis Push-In Suture Anchor

AlternatiV+ Max Knotless Anchor

AlternatiV+ Screw-In Anchor

Recalling firm: Aju Pharm Co., Ltd., Seongnam, N/A, Korea (the Republic of).

How to identify it

Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots. Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots. Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots. Model No. 10N47502, 10N55002; All UDI Codes; All Lots. Model No. 10KPN4751, 10KPN5501; All UDI Codes; All Lots. Model No. 10S30002; All UDI Codes; All Lots. Model No. 20KPN4751, 20KPN5501; All UDI Codes; All Lots. Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots.

The hazard

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

What to do

Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.

The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.

Where it was sold

US Nationwide distribution in the states of CA & PR.

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.

Read the official notice (opens in a new tab)