Device recall
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
- Recall number
- Z-0153-2027
- Event id
- 99754
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Ethicon, LLC
- Report date
- Oct 21, 2026
- Posted
- Oct 14, 2026
- Initiated
- Sep 8, 2026
- Center classification date
- Oct 14, 2026
- Product code
- GAQ
- Device type
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Reason
- Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
- Root cause
- Process control
- Quantity
- 1764
- Code info
- UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of SC, PA, TX, CA, ID, LA, MO, AL, NC, UT, IL, MA, OH, AZ, TN, OK, NE, ME, IN, WI, FL, CO, WY, NH, NY, NC, MN and the country of CA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K946173
- Location
- San Lorenzo, PR, United States