Serrato Polyaxial Screw (Howmedica) – Length Discrepancy (2019)

Check Your Product

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

Reason for Recall

As stated by FDA

Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.

Recommended Action

Per FDA guidance

1. Please note this product has already been removed by your local Stryker Sales Representative and/or Stryker Branch or Agency. This communication is being made for notification purposes only; there are no additional product return requirements for this matter. 2. Please assist us in meeting our regulatory obligation by completing and signing the enclosed Product Recall Acknowledgment Form and email a copy to Stryker Spine at SpineRegulatoryActions@Stryker.com or fax the form to 201-575-4675. If you have any questions, please contact Christa Joisil or Matthew Kelleher from the Regulatory Compliance Team: Spine-RegulatoryActions@Stryker.com or 201.749.8090