Recall Z-1306-2018 ยท HRS Plate, Fixation, Bone
Zimmer Biomet, Inc.
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
| Date | Oct 25, 2017 |
| Status | Terminated |
| Reason | The drill guides were manufactured with the incorrect color anodization. |
| Root cause | Unknown/Undetermined by firm |
| Action | DISTRIBUTORS: Review this notification and ensure that affected team members are aware of the contents. 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a c |
| Quantity | 22 |
| Distribution | Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands. |
| FDA record | Open on fda.gov |