FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Recall number
- Z-1536-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Status
- Terminated
- Initiated
- 2017-12-11
- Posted
- not on file
- Terminated
- 2020-09-21
- 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.
- Root cause
- Employee error
- Action
- On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at FieldActions@smith-nephew.com
- Quantity
- 22
- Distribution
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
- Lot, serial or model codes
- Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
- 510(k) numbers
- ["K952535"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28