Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk
Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are classified as Severe (Score 4).
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling the Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm (Catalog Number: 5100-060-001). This sterile, single-use cutting accessory is intended for cutting an 11 mm diameter access hole through the cranium of adult patients. The recall involves 18,492 devices, with an expanded total of 18,594 devices.
The recall is due to a potential for the inner bit to contain a crack, which may or may not be visible. This defect may lead to metal fragments entering the surgical site and/or delayed disengagement during use. The agency has classified this recall as Class II.
The devices were distributed nationwide and in foreign countries including Australia, Brazil, Canada, Chile, Colombia, Hong Kong, Italy, Mexico, Netherlands, New Zealand, South Africa, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. Healthcare facilities should stop using the affected devices and contact Stryker for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Distribution
Distributed nationwide across the United States.
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