Reported Oct 16, 2019 · Terminated
YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5…
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?
- YUKON Polyaxial Screws (3.5 X 12 mm
- Owning Site
Leesburg USA 3.5 X 14 mm3.5 X 32 mm3.5 X 34 mm3.5 X 38 mm3.5 X 40 mm4.0 X 16 mm4.0 X 18 mm4.0 X 20 mm4.0 X 22 mm4.0 X 24 mm4.0 X 26 mm4.0 X 28 mm4.0 X 30 mm5.0 X 22 mm5.0 X 28 mm5.0 X 30 mm) Catalog Numbers 7601-035127601-035147601-035327601-035347601-03538L7601-03540L7601-04016L7601-04018L7601-04020L7601-04022L7601-04024L7601-04026L7601-04028L7601-040307601-050227601-050287601-05030
- Lot codes and dates
- Lots FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL,FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV
- Amount recalled
- 364
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as part of Stryker's retrospective review of K2M product field actions; the action was completed in 2018.
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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