Reported May 27, 2020 · Terminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog #…
K2M, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428
Is this the product you have?
K2MALEUTIAN Interbody Spacer SystemsEN AN Lordotic SpreaderStainless SteelNon-SterileQty 1Catalog # 5203-90157UDI # 10888857108707Size 28x12mm6
- Product UsageUsed to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy
- Lot codes and dates
- Lot # FKXN
- Amount recalled
- N/A
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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