Food, drugs, devices › Ebi, Llc
Device recall: Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Ebi, Llc (Parsippany, NJ) initiated this device recall on 15 May 2014; FDA lists 1 product record under event 68526, 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Apr 2017. 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
"The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure."
Distribution
"Worldwide Distribution - USA (nationwide) and the country The Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1811-2014 | Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System. | 32 units (30 domestic and 2 international) | Class II | Terminated | 25 Jun 2014 |
Context
Other enforcement events for Ebi, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure."
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: "Worldwide Distribution - USA (nationwide) and the country The Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Apr 2017. "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.