Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
K2M Recalled by K2M, Inc Due to The Aleutian Anatomically Narrow Lordotic Spreader was manufactured...
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 K2M, Inc directly.
Affected Products
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.
Quantity: N/A
Why Was This Recalled?
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About K2M, Inc
K2M, Inc has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report