Z-0532-2024 Class II Ongoing
FDA device recall Z-0532-2024 was initiated by Encore Medical, LP on Sep 6, 2023 and is designated Class II. Reason for recall: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver The recall status is ongoing. Affected quantity: 146 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 20, 2023
- Initiation Date
- Sep 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146 units
Product description
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Reason for recall
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Distribution pattern
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
Code information
Part Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0532-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026