Encore Medical, LP Recall 93428
Description: RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Encore Medical, LP Recall 93428 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0532-2024 |
| Event ID | 93428 |
| Event Description | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device. |
| Product Type | Devices |
| 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 |
| Quantity | 146 units |
| Recall Reason | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver |
| Device Classification | 20231220 |
| Device Code Info | Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893 |
| Center Classification Date | 20231212 |
| Recall Initiation Date | 20230906 |
| Recalling Firm | Encore Medical, LP |
| Initial Notification | Letter |
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