# Class II recall Z-0153-2027: Ethicon, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0153-2027 |
| Recalling firm | Ethicon, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H |
| 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. |
| 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. |
| Recall initiated | 2026-09-08 |
| Reported | 2026-10-21 |
| Firm location | San Lorenzo, PR, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0153-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.