K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling 211 units of the Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader because the welded tip may break off during surgical 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 the hazard involves a structural defect (tip breakage) in a surgical instrument used during spinal procedures, which aligns with the rubric criteria for significant injury risk or structural defects.
Plain-English summary
K2M, Inc. is recalling 211 units of the Aleutian Interbody Spacer Systems, EN AN Lordotic Spreader, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm. The recalled 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 spinal surgery.
The affected units, identified by Lot # FKWV, 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 K2M, Inc. for further instructions.
The recalled product
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implan
- Manufacturer
- K2M, Inc
- Affected units
- 211
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 # FKWV
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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