YUKON Polyaxial Screws — Class II medical device recall Z-0110-2020
Terminated recall by K2M, Inc, reported 2019-10-16, distributed in AL, CA, CO, FL, IL, KY, LA, MD…. Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw
| Recall number | Z-0110-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2018-07-24 |
| Classified | 2019-10-09 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-10-01 |
| Distributed | AL, CA, CO, FL, IL, KY, LA, MD, MI, MN, MS, NC, NJ, NY, OH, OK, PA, TN, TX, WA |
| Countries outside the US | AU |
| Quantity | 364 |
| Model 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 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0110-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.