Generic Name: Absorbable Ligament Fixation Device — Brand Name: Bc Tenodesis Screw
Recall Summary BC Tenodesis Screws (model numbers AR-1540CDS and AR-1555CDS) used to attach ligaments and tendons to bone are being recalled by Arthrex Japan LLC because certain components were supplied by an unauthorized manufacturer not approved in the product authorization. The affected products were distributed in July and August 2025, and the company has not received any reports of health problems from these devices.
- Recalling firm
- Name of Manufacturer and Distributor: Arthrex Japan LLC — Address of Manufacturer and Distributor: Shinjuku NS Building, 2-4-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo — Type of License: Class I Medical...
- Product
- Lot: 対象品番：AR-1540CDS 対象ロット及び数量：15423340(1個) 出荷時期：2025年7月23日 対象品番：AR-1555CDS 対象ロット及び数量：15435610(1個), 15442203(3個) 出荷時期：2025年7月18日(*)〜2025年8月5日. Use: 本品は、靭帯、腱等の軟部組織、人工靭帯又は骨片を骨に結合するために用いる。. Health hazards: 回収対象の製品に使用されている原材料の仕様は承認書に記載されたものと同等であるため、当該製品を使用し たことで重篤な健康被害が発生する可能性はないと考えております。尚、これまでに本事象による健康被害の報 告は受けておりません。
- Reason
- We have discovered that the AR-1555CDS and AR-1540CDS components of the “BC Tenodesis Screw” were supplied by a supplier not listed in the manufacturing and marketing authorization. As a result, we have decided to conduct a voluntary recall of the affected products.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/5d3ece1a-0859-4be3-91f5-ce649c220270