K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is the tip breaking off during a procedure, but the source text does not report any specific injuries or illnesses.
Plain-English summary
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader, a medical device used to simulate the height of a cage and expand the spine disc space to determine the optimal implant size. The specific product affected is the Stainless Steel, Non-Sterile version, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18, Lot # FKXH.
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 while the instrument is in 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 units 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 # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
- Manufacturer
- K2M, Inc
- Hazard
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 # FKXH
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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