Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Reported: May 2, 2018 Initiated: December 11, 2017 #Z-1536-2018
Product Description
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 22
- Distribution
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015. Recalled by Smith & Nephew, Inc.. Units affected: 22.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1536-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11