Z-0153-2027

PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5

Name: Z-0153-2027 PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5
Creator: Ethicon, LLC
Published: 2026-09-08
License: https://open.fda.gov/license/

Ethicon, LLC / initiated 2026-09-08 / Open, Classified

FDA source

Recall record

Recall number: Z-0153-2027
Status: Open, Classified
Initiated: 2026-09-08
Posted: 2026-10-14
Recalling firm: Ethicon, LLC
Product: PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Product code: GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Reason for recall: 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.
FDA 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 [email protected] 4) Return affected product using the shipping label provided. In addition distributors were told the following: Based on your reported sales data, Ethicon will send notices directly to customers about the product subject to this recall. This notice will include instructions on returning the product for credit reimbursement. Distribute this notice within your organization and to any non-customer organization that received affected product from your facility. If you have additional questions regarding this communication or want to report any product complaints, please contact the firm's Resource Department at 1-877-384-4266.
Quantity in commerce: 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.
Product codes and lots: UDI-DI:Box/Unit: 30705031047369/10705031047365. Lot: RLBDPJ. Expiration: SEPTEMBER 30, 2026

Product code GAQ

K946173Class IIStainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and SilkETHICON, Inc. / cleared 1995-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-16. View this recall on fda.gov (opens on fda.gov)