Recall Z-0532-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, LP
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
| Date | Dec 12, 2023 (initiated Sep 6, 2023) |
| Status | Open, Classified |
| Reason | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver |
| Root cause | Component design/selection |
| Action | On 9/6/2023, the firm sent an email, "SE190 URGENT PLEASE READ-QUARANTINE NOTICE" stating that "identified a potential issue" with the RSP BASEPLATE, 30MM, W/P2 COATING". This email instructed customers to "Please reply all to this email when you've located the part(s) and have it quarantined. We will provide further instruction as soon as possible. Please do not request an RMA at this time". On 11/10/2023, the firm sent via email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the RSP Glenoid Baseplate was found to have an undersized hex, preventing engagement wit |
| Quantity | 146 units |
| Distribution | U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112069 | RSP GLENOID BASEPLATE POROUS COATED Encore Medical L.P., Nov 15, 2011 |