K2M Recalls Yukon Polyaxial Screws Due to Manufacturing Error
K2M, Inc. is recalling Yukon Polyaxial Screws because a manufacturing error may prevent them from mating with the screw inserter or set screw as intended.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (inability to mate with tools) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
K2M, Inc. is recalling 364 units of Yukon Polyaxial Screws in various sizes and catalog numbers. The recall was initiated due to a manufacturing error that could prevent the screws from mating with the screw inserter or set screw as intended.
The affected products were distributed to accounts in Alabama, California, Colorado, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington, as well as to Australia. The specific lot codes involved are FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL, FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, and FUXV.
This event was reported to the FDA as part of Stryker's retrospective review of K2M product field actions, and the action was completed in 2018. Healthcare providers and facilities should check their inventory for these specific lot codes and sizes and stop using the affected devices if found.
The recalled product
- Product
- 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 X 40 mm, 4.0 X 16 mm, 4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 26 mm, 4.0 X 28 mm, 4.0 X 30 mm, 5.0 X 22 mm, 5.0 X 28 mm, 5.0 X 30 mm) Cat
- Manufacturer
- K2M, Inc
- Affected units
- 364
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 (18)
- Lots FUVD
- FUVE
- FUVG
- FUWF
- FUWK
- FUWL
- FUWU
- FUWV
- FUWW
- FUXK
- FUXL
- FUXM
- FUXN
- FUXP
- FUXR
- FUXT
- FUXU
- FUXV
Distribution
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