ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1314-2021.
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1314-2021.
Recall terminated by FDA.
✅ 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 Depuy Orthopaedics, Inc. 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-1314-2021.
DePuy Orthopaedics, Inc.
About the U.S. Food and Drug Administration
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.
Depuy Orthopaedics, Inc. Recall FAQ
Depuy Orthopaedics, Inc. is the subject of a medical implants safety report: ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac.... The notice was published on February 22, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 102 units are potentially affected.