Class II — Smith & Nephew, Inc.
| Recalling firm | Smith & Nephew, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 |
| Quantity | 22 |
| Distribution | Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR. |
| Initiated | 2017-12-11 |
| Classified | 2018-04-26 |
| Terminated | 2020-09-21 |
| Recall number | Z-1536-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Smith & Nephew, Inc. (Z-1536-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79700/
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