Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures — Class II medical device recall Z-1536-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-05-02, distributed in AZ, ME, NY, OH, PA, PR, TN, VT. Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch
| Recall number | Z-1536-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Mansfield, MA, United States |
| Recall initiated | 2017-12-11 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-09-21 |
| Distributed | AZ, ME, NY, OH, PA, PR, TN, VT |
| Quantity | 22 |
| Reason classes | sterility |
| Lot numbers | 50498479, 50526605, 50527117, 50553176, 50579348, 50581344, 50588245, 50590542, 50591919, 50592295, 50603355 |
Product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Reason for recall
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1536-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.