K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 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.
Reported: May 27, 2020 Initiated: April 13, 2020 #Z-2009-2020
Product Description
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 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.
Details
- Recalling Firm
- K2M, Inc
- Units Affected
- N/A
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.
- Location
- Leesburg, VA
Frequently Asked Questions
What product was recalled? ▼
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 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.. Recalled by K2M, Inc. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2009-2020.
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