CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

Stryker Tapered Router recalled by Stryker Instruments

Stryker Instruments is recalling Stryker Tapered Router, distributed nationwide in the US. The recall was initiated on 24 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027

Quantity recalled543

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1478-2022
FDA event ID: 90535
Recalling firm: Stryker Instruments, Portage, MI
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2022
FDA classified: 28 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

24 Jun 2022	Recall initiated by company
28 Jul 2022	Classified by FDA	+34 days
3 Aug 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arizona California Florida Georgia Iowa Michigan Missouri North Carolina New Mexico Ohio Texas Virginia

Questions about this recall

Is Stryker Tapered Router recalled?

Yes. Stryker Instruments recalled Stryker Tapered Router on 24 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1478-2022.

Why was it recalled?

Which lots are affected?

UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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