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stryker Precision Thin, Catalog Number REF 2296-003-155 recallZ-1139-2025 · Stryker Corporation · initiated Jan 8, 2025

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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

FDA root cause category: Process control

What the company is doing

Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.

Recall details

Recall number
Z-1139-2025
Status
Open, Classified
Initiated by the company
Jan 8, 2025
Posted by the FDA
Feb 11, 2025
Recalling firm
Stryker Corporation
Quantity
238 units
Product code
GEI
Distribution
Worldwide distribution.

Product description

stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades

Code information (models, lots, serial numbers)

GTIN 04546540466549, Lot Number 23070017

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96098).

Sources and updates

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