Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SPII Model Lubinus Recalled by Waldemar Link GmbH & Co. KG (Mfg Site) Due to Due to two complaints, has come to our...

Date: February 6, 2024
Company: Waldemar Link GmbH & Co. KG (Mfg Site)
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Waldemar Link GmbH & Co. KG (Mfg Site) directly.

Affected Products

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Quantity: 153 Units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Waldemar Link GmbH & Co. KG (Mfg Site)

Waldemar Link GmbH & Co. KG (Mfg Site) has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report