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 | Sterility of device maybe compromised |
| Product | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair. |
| Quantity | 202,279 units |
| Distribution | Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden,… |
| Initiated | 2015-04-30 |
| Classified | 2015-06-22 |
| Terminated | 2017-09-19 |
| Recall number | Z-1822-2015 |
| 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-1822-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71257/
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