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

FDA device recall Z-0532-2024 · posted 2023-12-12 · Open, Classified

Recall details

Recalling firm

Encore Medical, LP

Reason for recall

Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver

Action taken

On 9/6/2023, the firm sent an email, "SE190 URGENT PLEASE READ-QUARANTINE NOTICE" stating that "identified a potential issue" with the RSP BASEPLATE, 30MM, W/P2 COATING". This email instructed customers to "Please reply all to this email when you've located the part(s) and have it quarantined. We will provide further instruction as soon as possible. Please do not request an RMA at this time". On 11/10/2023, the firm sent via email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that the RSP Glenoid Baseplate was found to have an undersized hex, preventing engagement with the Straight Mod Hexdriver and /or Hex Head Screw Driver. Customers were instructed to: 1. Pass this notice to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. The customer will be provided with a shipping label to return the affected product. For questions, contact Livia Kuruvila at (914)450-3931 or by email at livia.kuruvila@enovis.com

Root cause

Component design/selection

Status

Open, Classified

Product code

PHX

Quantity 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

Date initiated

2023-09-06

Date posted

2023-12-12

Location

Austin, TX

Related 510(k) clearances