Medical device manufacturer, Stryker, has issued a medical device safety alert concerning its Osteosynthesis Compression Staple EasyClip and EasyClip Xpress implants. The details of the affected products distributed in Hong Kong are identified as follows:

• Affected Product Number: EZ15-12-12, EZ15-15-15, EZ18-19-17, EZ25-22-22, EZM08-08-08 and EZM12-10-10
• Affected Lot Number: All

The manufacturer has identified a risk of a nickel release above the acceptable Margin of Safety for EasyClip implants. 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".

This risk was proactively identified following an update of the toxicological risk assessment for the Osteosynthesis Compression Staple EasyClip and EasyClip Xpress products. As of September 2020, the manufacturer is not aware of any complaints or incidents related to this potential risk.

According to the manufacturer, the risk to health can be considered as very low with a potential elevated development of nickel ion hypersensitivity in the future. As the release is reduced to almost zero after a month and with the highest release occurring in the first days it is very unlikely that the existing threshold value will be exceeded and therefore no action has to be recommended in these cases.

The manufacturer reminds the affected users that allergies due to Nickel release are mentioned in the PRECAUTIONS FOR USE section of the affected products:

• EasyClip IFU V15082 - "The implants contain metals which may stimulate allergic hypersensitive responses by the immune system".
• EasyClip Xpress IFU V15221 - "The implants contain metals which may stimulate allergic hypersensitive responses by the Immune system. In the specific case of metallic alloys composed of Nickel and Titanium (Ni and Ti), some preoperative testing should be conducted when sensitivity is suspected. A surgeon should not attempt clinical use of an implant before reviewing instructions for use and/or rehearsing the installation procedure in a skills laboratory."

The manufacturer emphasizes that the product can be used according to the instructions for use, with the limitation of a maximum of two implants in pediatric patients. This is not an action to remove devices.

According to the local responsible person, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 30 September 2020