Device product
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Z-1811-2014
Product summary
- Firm
- Ebi, Llc
- Event
- Event 68526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32 units (30 domestic and 2 international)
- Official record key
device-enforcement:Z-1811-2014
Official wording
Reason: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Code information: Catalog Number 14-501669; Lot Number 006731
Distribution pattern: Worldwide Distribution - USA (nationwide) and the country The Netherlands.
Derived failure modes
-
Unknown
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.