MaxAn 4 — Class II medical device recall Z-0203-2016
Terminated recall by Biomet Spine, LLC, reported 2015-11-11, distributed in FL, MO, NY. The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
| Recall number | Z-0203-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine, LLC, Broomfield, CO, United States |
| Recall initiated | 2015-09-29 |
| Classified | 2015-11-03 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-04-29 |
| Distributed | FL, MO, NY |
| Quantity | 17 units |
| Reason classes | labeling |
| Lot numbers | 14-521518, 14-521548, 463870, J26394, J86056 |
| Model numbers | 14-521518, 14-521520, 14-521548, 14-521550 |
Product
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Reason for recall
The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.
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-0203-2016. 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.