K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Lordotic Spreader because the welded tip may break off during spinal procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (tip breakage) in a surgical instrument, which poses a risk of significant injury during a procedure.
Plain-English summary
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader, a stainless steel, non-sterile medical device used to simulate cage height and expand spine disc space. The recall is due to a manufacturing defect where the spreader tip, which is welded to the main body, may break off during the procedure.
The affected product is identified by Lot # FKXF. Distribution was worldwide, including nationwide distribution in the United States across states such as Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, and Missouri, as well as in Europe.
Healthcare providers should stop using the affected devices and contact K2M, Inc. for further instructions on the recall.
The recalled product
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
- Manufacturer
- K2M, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # FKXF
Distribution
Part of a larger recall action
This product is one of 24 recalled by K2M, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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