BIOMET Spine — Class II medical device recall Z-0359-2014
Terminated recall by Ebi, Llc, reported 2013-11-27, distributed nationwide. Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally descri
| Recall number | Z-0359-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2013-08-22 |
| Classified | 2013-11-19 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2016-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 7,092 units |
Product
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Reason for recall
Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.
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-0359-2014. 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.