Polaris 4 — Class II medical device recall Z-2152-2015
Terminated recall by Biomet Spine, LLC, reported 2015-07-29, distributed nationwide. Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result a
| Recall number | Z-2152-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine, LLC, Parsippany, NJ, United States |
| Recall initiated | 2015-03-12 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-12-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 4,765 units |
| Reason classes | potency, specification failure |
| Model numbers | 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-582325, 14-582330, 14-582335, 14-582340 and 35 more |
Product
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
Reason for recall
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
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-2152-2015. 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.