Recall Z-2021-2020— K2M, Inc
Class II · Terminated
Class II FDA medical device recall by K2M, Inc, initiated 2020-04-13, terminated 2021-11-15. FDA's recall record names no specific 510(k) clearance for this event. Product: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.. Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure..
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-13
- Terminated
- 2021-11-15
- Firm location
- Leesburg, VA, United States
Product description
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.
Reason for recall
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.