Recall Z-1378-2022— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-1378-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-24

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2022-05-24. It names one FDA 510(k) clearance: K212742. Product: Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.. Reason: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2022-05-24
Firm location: Norderstedt, Germany

510(k) clearances named in this recall

1 on FDA's record

K212742 — GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingWaldemar Link GmbH & Co. KG·cleared 2021-09-16

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

Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.

Reason for recall

There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

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