Recall Z-2288-2025— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-2288-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-15

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2025-07-15. It names one FDA 510(k) clearance: K953653. Product: Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.. Reason: Inconsistent size terminology and color coding used on labeling.

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2025-07-15
Firm location: Norderstedt, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K953653 — LUBINUS SP II HIP SYSTEMTurnkey Intergration USA, Inc.·cleared 1995-11-06

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

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Reason for recall

Inconsistent size terminology and color coding used on labeling

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