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 | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. |
| Product | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic |
| Quantity | 4 units |
| Distribution | USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN. |
| Initiated | 2013-10-07 |
| Classified | 2013-11-01 |
| Terminated | 2016-08-23 |
| Recall number | Z-0131-2014 |
| 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-0131-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66545/
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