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 | LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress. |
| Product | LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shorte… |
| Quantity | 116 devices |
| Distribution | Worldwide distributions - US Nationwide distributions and countries of Belgium, Brazil, China, Columbia, France, Great Britain, India, Japan, Russia, Singapore, South Africa, Spain,and United Arab Emirates. |
| Initiated | 2019-10-07 |
| Classified | 2019-11-08 |
| Terminated | 2023-03-08 |
| Recall number | Z-0351-2020 |
| 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-0351-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84059/
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