FDA Device recall Z-0536-2013
Biomet Polaris 5.5 Button Lock Screw Inserter
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Biomet Polaris 5.5 Button Lock Screw Inserter by Ebi, citing broken screw insertor hardness was measured and found to be below the acceptable limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0536-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-29 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ebi |
| Distribution | US |
Product
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Reason
Broken screw insertor hardness was measured and found to be below the acceptable limits.
Identifiers
| code_info | Lot Numbers 540199, 540199-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0536-2013%22
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