FDA-Device2023-12-20Class II
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Encore Medical, LP
Hazard
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Sold states
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
Affected count
146 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2024Don't want to check this manually?
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