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 | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| Product | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone |
| Quantity | N/A |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE |
| Initiated | 2017-03-15 |
| Classified | 2017-04-18 |
| Terminated | 2018-07-10 |
| Recall number | Z-1839-2017 |
| 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-1839-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76824/
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