FDA Device recall Z-1478-2022
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures by Stryker Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-24 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Instruments |
| Distribution | US |
Product
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2022%22
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