Recall Z-2641-2023— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-2641-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2023-07-14. It names one FDA 510(k) clearance: K200607. Product: MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination. Reason: Product is labeled with incorrect offset..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2023-07-14
Firm location: Norderstedt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K200607 — LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG·cleared 2021-05-28

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

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

Reason for recall

Product is labeled with incorrect offset.

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