EASYCLIP AGRAFE BIPODE MONOCORTICALE & BICORTICALE SUPERELASTIQUE (2020-09-23)

Starting date:

September 23, 2020

Posting date:

December 4, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74463

Last updated:
2020-12-03

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  Reason
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  Affected products

Affected Products

A. EASYCLIP AGRAFE BIPODE MONOCORTICALE SUPERELASTIQUE

B. EASYCLIP AGRAFE BIPODE BICORTICALE SUPERELASTIQUE

Reason

Stryker Trauma GmbH (Trauma & Extremities Division) has identified a risk of a nickel release above the acceptable Margin of Safety for EasyClip implants. This risk was proactively identified following an update of the toxicological risk assessment for the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress products July 8 2020. It was determined that pediatric patients with a body weight of less than 20 kg should have a maximum of 2 Easyclip staples implanted to remain in the acceptable Margin of Safety. Therefore, the current IFU will be updated, a contraindication will be added "Do not implant more than 2 EasyClip devices in pediatric patients ".

Affected products