K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal 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 involves a risk-of-harm product where the device tip can break off during a procedure, but the source text does not report any specific injuries or illnesses, meeting the criteria for a High severity score.
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 is issued because the device is manufactured as two pieces welded together, a design associated with the spreader tip breaking off during the procedure.
The affected product is identified by Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, and Lot # FKXU. Distribution was worldwide, including nationwide distribution in the United States and in Europe.
Healthcare providers should stop using the affected devices and contact K2M, Inc. for further instructions. Patients who have had this device used during a procedure should consult their healthcare provider if they have concerns.
The recalled product
- Product
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 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 # FKXU
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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