K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage
K2M, Inc. is recalling Aleutian Interbody Spacer Systems because the welded spreader tips 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 (welded tip breaking off) in a surgical instrument, which meets the rubric criteria for a Severe rating due to the risk of significant injury during a procedure.
Plain-English summary
K2M, Inc. is recalling the Aleutian Interbody Spacer Systems, specifically the EN AN Lordotic Spreader (Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm). The product is a stainless steel, non-sterile medical device used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size based on patient anatomy.
The recall was initiated because the spreader was manufactured as two pieces welded together, a design associated with the spreader tip breaking off during the procedure. This defect poses a risk of device failure during surgical use.
The affected products were distributed worldwide, including nationwide in the United States and in Europe. Specific US states mentioned in the distribution pattern include Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, and Missouri. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 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 # FKXX
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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