Reported Jan 14, 2015 · Terminated
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various…
Ebi, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ebi, Llc · 399 Jefferson Rd · Parsippany, NJ · 07054-3707
Is this the product you have?
- Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
- Lot codes and dates
- Item Number14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS
- Amount recalled
- 2816 approx.units ( 2688 units US and 128 OUS)
Where it was sold
Why it was recalled
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
This product could cause temporary or reversible health problems — stop using it.
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