Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices
Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (excessive nickel release) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker GmbH is recalling the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress devices. The recall covers all lots of these products, which are available in various sizes identified by specific product and catalog numbers.
The devices are being recalled because they have the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when two or more implants are used. The devices were distributed nationwide in the US and to countries outside the US. As of September 4, 2020, 121,517 EasyClip devices and 9,561 EasyClip Xpress devices had been distributed in the US.
Healthcare providers and patients should check if they have these specific devices implanted. If a patient weighs less than 20 kg and has two or more of these implants, they should consult their healthcare provider regarding the potential for nickel release.
The recalled product
- Product
- Osteosynthesis Compression Staple EasyClip
- Manufacturer
- Stryker GmbH
- Hazard
Distribution
Distributed nationwide across the United States.
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