Recall Z-0153-2027 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Ethicon, LLC
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
| Date | Oct 14, 2026 (initiated Sep 8, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 9/8/2026, recall notices were mailed to customers who were asked to do the following: 1) Quarantine affected products. Maintain a copy of this notice with the quarantined product and keep a copy for your records. 2) Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return and forward them this recall notice. 3) Complete and return the Business Reply Form via email to ethicon4483@sedgwick.com |
| Quantity | 1764 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK ETHICON, Inc., Jan 9, 1995 |