medical Class II Updated 2025-02-12

Ethicon, LLC recalls PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perm

Recalled Product

PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.


Hazard / Issue

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI-GTIN/Lot(expiration): F2416H/10705031238947/103E7C(8/31/2029); EH7808B/10705031239425/103E7A(8/31/2029); 661H/10705031007703/103GR7(8/31/2029), 103H5A(8/31/2029); 1669H/10705031001879/103GR2(8/31/2029), 103J14(8/31/2029); 644H/10705031089594/103EXA(8/31/2029); EH7827B/10705031239074/103EX9(8/31/2029); F3223BH/10705031240940/103EJH(8/31/2029); EH7797BH/10705031239487/103J2H(8/31/2029); 628H/10705031007000/1033PK(7/31/2029); 699G/10705031008625/102TMJ(7/31/2029); K872H/10705031044586/103DBT(8/31/2029); W723H/10705031202450/103G13(8/31/2029); 623H/10705031006898/10386S(8/31/2029); K833H/10705031044388/103K99(8/31/2029); 6664H/10705031089808/103G1B(8/31/2029); X425H/10705031057296/103H4B(8/31/2029); X872H/10705031058187/103DBT(8/31/2029); EH7491H/10705031096806/103D42(8/31/2029)
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