Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023… recallZ-1478-2022 · Stryker Instruments · initiated Jun 24, 2022
Class II Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Instruments or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process change control
What the company is doing
On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.
Recall details
- Recall number
- Z-1478-2022
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2022
- Recalling firm
- Stryker Instruments
- Quantity
- 543
- Product code
- HBE
- FDA submissions
- K143320
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.
Product description
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A 5820071023Stryker Corporation · DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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