K2M — Class II medical device recall Z-2013-2020
Terminated recall by K2M, Inc, reported 2020-05-27, distributed nationwide. The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has be
| Recall number | Z-2013-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2020-04-13 |
| Classified | 2020-05-15 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-11-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10888857108349 |
| Model numbers | 5203-90121 |
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.
Reason for recall
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.
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-2013-2020. 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.