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Stryker GmbH recalls Osteosynthesis Compression Staple EasyClip
Recalled November 25, 2020 · FDA recall Z-0457-2021 · Stryker
Hazard
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used. · FDA Class II
Units
121,517 EasyClip devices and 9,561 EasyClip Xpress devices distributed nationwide in US.
Sold at
The devices were distributed nationwide throughout the US, and to countries OUS. Easy Clip devices: As of 09/04/2020, 251,566 EasyClip devices have been manufactured. 121,517 of those devices were distributed to the US, and 102,529 were distributed in countries OUS. 27,520 devices were left in the firm's inventory. Easy Clip Xpress devices: As of 09/04/2020, 37,371 EasyClip Xpress devices have been manufactured. 9,561 of those devices were distributed to the US, leaving 27,810 in the firm's inventory. This device is only distributed in the United States.
Description
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
Product
Osteosynthesis Compression Staple EasyClip
Manufacturer(s)
Stryker GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →