Recall Z-1811-2014— Ebi, Llc
Class II · Terminated
Class II FDA medical device recall by Ebi, Llc, initiated 2014-05-15, terminated 2017-04-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.. Reason: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure..
- Recalling firm
- Ebi, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-15
- Terminated
- 2017-04-21
- Firm location
- Parsippany, NJ, United States
Product description
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Reason for recall
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.