Generic Name: Polypropylene Surgical Suture — Trade Name: Pp Surgical Suture-k

Recalling firm: Name of Manufacturer and Distributor: Kono Seisakusho Co., Ltd. — Address of Manufacturer and Distributor: 2-11-10 Soya, Ichikawa City, Chiba Prefecture — Type of License: Class I Medical Device...
Product: Lot: カタログNo.：CLA517 ロットNo.： 1000085985, 1000102519, 1000111639 出荷数量：3箱（36本）カタログNo.：CLB017 ロットNo.： 1000084021, 1000084289, 1000085587, 1000089096, 1000089097, 1000091407, 1000091408 1000092183, 1000093086, 1000093087, 1000094104, 1000094229, 1000094865, 1000095885 1000096561, 1000098772, 1000099397, 1000099911, 1000100937, 1000101898, 1000102634 1000103424, 1000104727, 1000105225, 1000105494, 1000105826, 1000107065, 1000107261 1000107960, 1000117948 出荷数量：284箱+10本（3,418本）カタログNo.：CLB027 ロットNo.： 1000084263, 1000085999, 1000092536, 1000092568, 1000092569, 1000092570, 1000099358 1000099359,...
Reason: We have discovered that among the suture threads purchased from a raw material manufacturer (received wound onto bobbins), a specific batch is prone to fuzzing on the thread surface due to friction. After conducting our own verification on inventory items manufactured using the same thread batch as the products found to have defects, we confirmed that similar defects may occur. We have also confirmed that this defect does not occur with other thread lots. Therefore, we have decided to voluntarily recall all products manufactured and shipped using thread from the same lot as the products...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/431cf0ca-11ce-4183-863c-3044241966f5