NAVIO Soft Tissue Protector — Class II medical device recall Z-1634-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-04-08, distributed nationwide. Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when i
| Recall number | Z-1634-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-02-27 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2024-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, FR, GB, TH, TR |
| Quantity | 348 units |
| Lot numbers | 2067, 2212, 3809, 3869, 4354, 5228, 5337, 5494, 5514, 5887, 6248 |
Product
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navio bone clamps and potentially reduce the amount of patient tissue affected when placing the bone pins.
Reason for recall
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1634-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.