Generic Name: Total Shoulder Arthroplasty — Brand Name: Echinox Shoulder System

Recalling firm: Name of Manufacturer and Distributor: Exactech Co., Ltd. — Address of Manufacturer and Distributor: PMO Nihonbashi 2-chome, 2-15-5 Nihonbashi, Chuo-ku, Tokyo — Type of License: Class I Medical...
Product: Lot: ヒューメラルライナー対象数量 644個出荷時期 2020年10月16日〜 2025年8月13日製品番号： 320-38-00 シリアル番号： 7285091 7285095 7285140 7285141 7285147 7285163 7285169 7285174 7285182 7285198 7285203 7285246 7285264 7285268 7285272 7290735 7290737 7303897 7303908 7303910 7303911 7303922 7304038 7304046 7310388 7310455 A009560 A009561 A022864 A022868 A093424 A143722 A143765 A143782 A164593 A164600 A164604 A164646 A164648 A164674 A164756 A164763 A164764 A164774 A177639 A297208 A297218 A340733 A400740 A400757 A400788 A400792 A461018 A461028 A461032 A461036 A461037 A549757 A549774 A549795 A549801 A550002 A554565 A554567...
Reason: This product is an artificial shoulder joint implant consisting of components on the scapular side (glenoid baseplate and glenosphere) and the humeral side (humeral liner and humeral stem). We have received notification from the manufacturer regarding a voluntary recall after it was confirmed that some units of the humeral liner—one of the components—may have been manufactured with a slight misalignment at the pivot point (the deepest part of the sliding surface) relative to the glenosphere. Consequently, we have decided to implement a similar recall in Japan.
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/7e454838-29fa-42e8-89fe-cacaff43372d