Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Universal Titanium Prosthesis Recalled by Medtronic Xomed, Inc. Due to One lot of the product was assembled using...
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 Medtronic Xomed, Inc. directly.
Affected Products
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Quantity: 60
Why Was This Recalled?
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Xomed, Inc.
Medtronic Xomed, Inc. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report