Stryker 2 — Class II medical device recall Z-1478-2022
Ongoing recall by Stryker Instruments, reported 2022-08-03, distributed nationwide. There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break ca
| Recall number | Z-1478-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments, Portage, MI, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-07-28 |
| Reported by FDA | 2022-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, NL, TH |
| Quantity | 543 |
| Reason classes | foreign material, device malfunction |
| UPC / GTIN / UDI-DI | 07613327294910 |
| Lot numbers | 20139027, 20140017, 20216017, 21330017, 22011017 |
| Model numbers | 5820-071-023 |
Product
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Reason for recall
There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
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-1478-2022. 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.