Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab Recalled by Brainlab AG Due to The recommended sterilization and drying parameters are not...
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 Brainlab AG directly.
Affected Products
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
Quantity: 114 offset cup impactors
Why Was This Recalled?
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Brainlab AG
Brainlab AG has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report