FDA Device recall Z-0110-2020
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…
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of 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… by K2m, citing 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 ret….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0110-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-24 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | K2m |
| Distribution | AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, WA |
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) Catalog Numbers 7601-03512, 7601-03514, 7601-03532, 7601-03534, 7601-03538L, 7601-03540L, 7601-04016L, 7601-04018L, 7601-04020L, 7601-04022L, 7601-04024L, 7601-04026L, 7601-04028L, 7601-04030, 7601-05022, 7601-05028, 7601-05030
Reason
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.
Identifiers
| code_info | Lots FUVD, FUVE, FUVG, FUWF, FUWK, FUWL, FUWU, FUWV, FUWW, FUXK, FUXL,FUXM, FUXN, FUXP, FUXR, FUXT, FUXU, FUXV |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0110-2020%22
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