PlainRecalls
FDA Devices Moderate Class II Ongoing

RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.

Reported: December 20, 2023 Initiated: September 6, 2023 #Z-0532-2024

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

Details

Recalling Firm
Encore Medical, LP
Units Affected
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
Location
Austin, TX

Frequently Asked Questions

What product was recalled?
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.. Recalled by Encore Medical, LP. Units affected: 146 units.
Why was this product recalled?
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Which agency issued this recall?
This recall was issued by the FDA Devices on December 20, 2023. Severity: Moderate. Recall number: Z-0532-2024.