SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1298-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1298-2024.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Waldemar Link Gmbh & Co. Kg (mfg Site) or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1298-2024.
Waldemar Link GmbH & Co. KG (Mfg Site)
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Waldemar Link Gmbh & Co. Kg (mfg Site) Recall FAQ
Waldemar Link Gmbh & Co. Kg (mfg Site) is the subject of a medical implants safety report: SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented. The notice was published on February 6, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 153 units are potentially affected.