Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Reported: June 25, 2014 Initiated: May 15, 2014 #Z-1811-2014
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.
Details
- Recalling Firm
- Ebi, Llc
- Units Affected
- 32 units (30 domestic and 2 international)
- Distribution
- Worldwide Distribution - USA (nationwide) and the country The Netherlands.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.. Recalled by Ebi, Llc. Units affected: 32 units (30 domestic and 2 international).
Why was this product recalled? ▼
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1811-2014.
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