K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may 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 (medical device breakage) where injury has not yet been reported, fitting the High severity criteria.
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 due to a manufacturing defect where the two-piece welded design has been associated with the spreader tip breaking off during the procedure.
The affected product is identified by Lot # FKWY, Catalog # 5203-90113, and UDI # 10888857108264. The device was distributed worldwide, including in the United States and Europe. The source text does not specify the number of units affected or report any specific patient injuries or illnesses.
Healthcare providers should stop using the affected spreaders 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 # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
- 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 # FKWY
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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