Recall Z-0532-2024— Encore Medical, LP

Name: FDA recall Z-0532-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-06

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-09-06. It names one FDA 510(k) clearance: K112069. Product: RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.. Reason: Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver.

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-09-06
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K112069 — RSP GLENOID BASEPLATE POROUS COATEDEncore Medical L.P.·cleared 2011-11-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.