Recall Z-2046-2023— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-2046-2023
Creator: U.S. Food and Drug Administration
Published: 2021-03-18

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2021-03-18. It names one FDA 510(k) clearance: K143179. Product: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right. Reason: The firm discovered through customer complaints that device segments may not meet specifications..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2021-03-18
Firm location: Norderstedt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K143179 — The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG·cleared 2015-01-30

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

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right

Reason for recall

The firm discovered through customer complaints that device segments may not meet specifications.

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