K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.
What this means for you
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 is classified as FDA Class II and involves a risk-of-harm product (surgical instrument breakage) where specific injury counts are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
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 involves Lot # FKXE, Catalog # 5203-90127, and UDI # 10888857108400. The device is distributed worldwide, including in the United States and Europe.
The recall is due to a manufacturing defect where the spreader, which is manufactured as two pieces welded together, has been associated with the spreader tip breaking off during the procedure. This breakage presents a risk of harm to patients during spinal surgery.
Healthcare providers and facilities that have received this product should stop using it immediately. Patients who have had this device used during a procedure should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impl
- 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 # FKXE
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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