Recall Z-2300-2020 ยท PHX Shoulder Prosthesis, Reverse Configuration
Biomet, Inc.
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
| Date | May 11, 2020 |
| Status | Terminated |
| Reason | The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device. |
| Root cause | Under Investigation by firm |
| Action | On May 11, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Distributors were asked to return all affected product from their distributorship and from affected hospitals within their territory. Distributors should identify whether there are any additional hospitals that the recalling firm has not notified and provide a list of these additional accounts to Zimmer Biomet. Risk managers at hospitals were asked to take the following actions: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected pro |
| Quantity | 38 |
| Distribution | US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) Biomet Manufacturing Corp, May 16, 2016 |