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Recall Observatory FDA recall evidence

Device 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.

Z-1097-2025

December 20, 2024

Class II

Product summary

Firm
Ethicon, LLC
Event
Event 96127
Status
Ongoing
Classification
Class II
Quantity
78792
Official record key
device-enforcement:Z-1097-2025

Official wording

Reason: 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.

Code information: 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)

Distribution pattern: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and the countries of AT, AU, BE, CA, CH, CN, CZ, DE, DK, FI, FR, GB, HU, IE, JP, LU, NL, NO, PL, SE, SG, ZA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach in sterility