CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

Precision Thin recalled by Stryker

Stryker is recalling stryker Precision Thin. The recall was initiated on 8 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 04546540046482, Lot Number 22298017

Quantity recalled622 units

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-1138-2025
FDA event ID: 96098
Recalling firm: Stryker, Portage, MI
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jan 2025
FDA classified: 11 Feb 2025
Reported: 19 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jan 2025	Recall initiated by company
11 Feb 2025	Classified by FDA	+34 days
19 Feb 2025	Published in enforcement report	+8 days

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

Reason for recall

Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Product as listed by the FDA

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Precision Thin recalled?

Yes. Stryker recalled Precision Thin on 8 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1138-2025.

Why was it recalled?

Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Which lots are affected?

GTIN 04546540046482, Lot Number 22298017

Where was it sold?

Worldwide distribution.

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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