Recall Z-1615-2020

Reason for recall

Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.

FDA-determined cause: Packaging process control

Action taken

Zimmer Biomet issued notification letter on 2/25/20 via email to the International consignees states reason for recall, health risk and action to take: Hospital Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certification of Acknowledgement Form and send to fieldaction.emea@zimmerbiomet.com.This form must be returned even if you do not have affected products available to return in your facility. 5. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative.