Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker Zyphr Disposable Cranial Perforator Recalled by Stryker Instruments Div. of Stryker Corporation Due to Potential for the inner bit to contain a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.
Affected Products
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
Quantity: 18,492 devices. Expanded Recall total: 18,594 devices
Why Was This Recalled?
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report