Food, drugs, devices › Ebi, Llc
Device recall: Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Ebi, Llc (Parsippany, NJ) initiated this device recall on 29 Sep 2012; FDA lists 1 product record under event 63653, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 7 Dec 2015. Initiation: voluntary: firm initiated. Ebi, Llc has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ebi, Llc, Parsippany, NJ.
Reason for recall
"Broken screw insertor hardness was measured and found to be below the acceptable limits."
Distribution
"Nationwide Distribution, including the states of MO, TX, and IN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0536-2013 | Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 | 15 units | Class II | Terminated | 26 Dec 2012 |
Context
Other enforcement events for Ebi, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Broken screw insertor hardness was measured and found to be below the acceptable limits."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution, including the states of MO, TX, and IN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.