Recall Z-1131-2021 ยท PHX Shoulder Prosthesis, Reverse Configuration
Biomet, Inc.
Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
| Date | Jan 15, 2021 |
| Status | Terminated |
| Reason | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. |
| Root cause | Labeling Change Control |
| Action | On 01/19/2019, Zimmer Biomet issued Urgent Medical Device Recall notices to distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. |
| Quantity | 49 |
| Distribution | US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS Biomet Manufacturing Corp, Sep 6, 2013 |