Z-1811-2014 Class II Terminated
FDA device recall Z-1811-2014 was initiated by Ebi, Llc on May 15, 2014 and is designated Class II. Reason for recall: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure. The recall status is terminated (terminated April 21, 2017). Affected quantity: 32 units (30 domestic and 2 international).
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- May 15, 2014
- Termination Date
- April 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units (30 domestic and 2 international)
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the country The Netherlands.
Code Information
Catalog Number 14-501669; Lot Number 006731