Recall Z-1297-2024— Waldemar Link GmbH & Co. KG (Mfg Site)

Name: FDA recall Z-1297-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-06

Class II · Ongoing

Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2024-02-06. It names one FDA 510(k) clearance: K953653. Product: SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented. Reason: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery..

Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site)
Classification: Class II
Status: Ongoing
Initiated: 2024-02-06
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

SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

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