FDA Device recall Z-1536-2018
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures by Smith And Nephew, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1536-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-11 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | AZ, ME, NY, OH, PA, PR, TN, VT |
Product
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Reason
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.
Identifiers
| code_info | Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1536-2018%22
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