K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 aligns with the rubric criteria for 'Severe' severity involving significant injury risk or structural defects.
Plain-English summary
K2M, Inc. is recalling the Aleutian Interbody Spacer Systems, specifically the EN AN Lordotic Spreader (Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm). The recalled items are stainless steel, non-sterile instruments used to simulate cage height and expand spine disc space to determine 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 injury or procedural failure during spinal surgery.
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 lots immediately and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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…
- 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 # FKXW
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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