FDA recall Z-0532-2024

Encore Medical, LP · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-09-06
Report date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2024