Stryker GmbH Bohnackerweg 1 Selzach Switzerland Osteosynthesis Compression Staple EasyClip Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

All affected customers were mailed an Urgent Medical Device Correction (UMDC) letter on 09/25/2020 that requested them to take the following actions: 1. Please inform users of this Urgent Medical Device Correction (UMDC) and forward this notice to all individuals who need to be made aware of the recall. 2. Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing soprodexpreports@stryker.com. 3. A response is required, even though you may not have any physical inventory on site anymore. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form and fax a copy to 1-888-240-4294 or email to StrykerOrtho5568@Stericycle.com. 5. Branches/Agencies Only: Please forward this Urgent Medical Device Correction to the individuals or organizations who have consigned product, if applicable. Please assist us in meeting our regulatory obligation by faxing back the attached Urgent Medical Device Correction Business Reply Form within 5 days. We regret any inconvenience this action may cause you and if you have any questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com