Ethicon, LLC: Device Recall

Recall Details

Recall Number

Z-1097-2025

Classification

Class II

Product Type

Device

Recalling Firm

Ethicon, LLC

Status

Ongoing

Date Initiated

12/20/2024

Location

San Lorenzo, PR, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

78792

Reason for Recall

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.

Product Description

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.

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.

Other Recalls by Ethicon, LLC

• Class II: Risk 08/15/2025
  Potential for barb non-engagement.
• Class II: Risk 12/20/2024
  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.
• Class II: Risk 12/20/2024
  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.

View all recalls by Ethicon, LLC →