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 | Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm. |
| Product | smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis. |
| Quantity | 13 units |
| Distribution | US nationwide distribution. |
| Initiated | 2018-05-02 |
| Classified | 2018-05-23 |
| Terminated | 2020-09-01 |
| Recall number | Z-1921-2018 |
| 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-1921-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80050/
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