Z-1478-2022Class II

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures

Name: Z-1478-2022 Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures
Creator: Stryker Instruments
Published: 2022-06-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2022-06-24 / Open, Classified

FDA source

Stryker Instruments began a recall of Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures on 2022-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1478-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-07-28
Recalling firm: Stryker Corp.
Product: Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 543
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 codes and lots: UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-28

Product code HBE

K143320Class IIStryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. / cleared 2015-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)