Warsaw Orthopedic, Inc.
2500 SILVEUS CROSSING, WARSAW, IN, US
Registered product codes
85 product codes
Recent MDR events
2,912 on file
- Catalyft¿ PL Expandable Interbody SystemJul 28, 2026Malfunction1824199-2026-00078
- BRYAN® CERVICAL DISC SYSTEMJul 22, 2026Injury1824199-2026-00076
- CD HORIZON® SOLERA® SPINAL SYSTEMJul 22, 2026Malfunction1824199-2026-00077
- CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEMJul 7, 2026Malfunction1824199-2026-00075
- CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEMJul 6, 2026Malfunction1824199-2026-00073
- CATALYFT¿ PL EXPANDABLE INTERBODY SYSTEMJul 6, 2026Malfunction1824199-2026-00074
- CD HORIZON® SPINAL SYSTEMJul 2, 2026Malfunction1824199-2026-00071
- CD HORIZON® SPINAL SYSTEMJul 2, 2026Malfunction1824199-2026-00072
- CD HORIZON® SPINAL SYSTEMJul 1, 2026Malfunction1824199-2026-00069
- CD HORIZON® SPINAL SYSTEMJul 1, 2026Malfunction1824199-2026-00070
Recalls
16 on file
- TerminatedMar 12, 2009
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
View FDA record ↗ - TerminatedMar 12, 2009
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
View FDA record ↗ - TerminatedMar 12, 2009
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
View FDA record ↗ - TerminatedMar 12, 2009
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
View FDA record ↗ - TerminatedFeb 7, 2008
Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
View FDA record ↗ - TerminatedNov 7, 2007
Packaging weakness may compromise sterility and instructions for use are inadequate.
View FDA record ↗ - TerminatedAug 6, 2005
The product is labeled as sterile, but this lot was not sterilized.
View FDA record ↗ - TerminatedJul 13, 2005
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
View FDA record ↗ - TerminatedJul 13, 2005
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
View FDA record ↗ - TerminatedJul 13, 2005
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
View FDA record ↗
Compliance history
Matched by FEI 1824199.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.