Warsaw Orthopedic, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1824199
- Devices
- 24
- Registrations
- FDA
- FDA recalls
- 10
What Warsaw Orthopedic, Inc. makes
The company manufactures orthopedic fixation devices, including interlocking femoral and tibial nails for long-bone stabilization, bone plates (e.g., supracondylar and partially threaded fixation pins), and joint prostheses such as phalangeal and metacarpophalangeal components. Additional products include surgical tools like phalangeal component drivers, fixation staple drivers/extractors, and trial components for joint replacements. Hospital bed clothing, such as cradle systems, and systems for total shoulder replacements (e.g., TSR cross-link components) are also part of the portfolio.
These devices are regulated under FDA Class I and Class II classifications, with most requiring 510(k) clearance. The portfolio is listed in the FDA’s 510(k) registry, reflecting their authorization pathway. The company is based in the United States.
Catalogue
Search and filter all 24 devicesCompany details
- FDA FEI number
- 1824199
- Address
- 2500 SILVEUS CROSSING, WARSAW, IN, 46582
FDA recalls
FDA recall records list 10 recalls initiated by WARSAW ORTHOPEDIC, INC., the earliest on 2005-01-04 and the most recent on 2005-06-20. By recorded status: 10 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 20 Jun 2005 Z-0991-05 Unclassified (pre-2012) Terminated The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
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- 20 Jun 2005 Z-0992-05 Unclassified (pre-2012) Terminated The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
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- 20 Jun 2005 Z-0993-05 Unclassified (pre-2012) Terminated The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
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- 27 May 2005 Z-1090-05 Unclassified (pre-2012) Terminated The product is labeled as sterile, but this lot was not sterilized.
- 4 Jan 2005 Z-0446-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
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- 4 Jan 2005 Z-0447-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
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- 4 Jan 2005 Z-0448-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads iof the bone screws included in the kit.
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- 4 Jan 2005 Z-0449-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
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- 4 Jan 2005 Z-0450-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
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- 4 Jan 2005 Z-0451-05 Unclassified (pre-2012) Terminated The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.
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- 20 Jun 2005 Z-0991-05 Unclassified (pre-2012) Terminated The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Frequently asked questions
How many devices does WARSAW ORTHOPEDIC, INC. have in the registry?
The registry currently lists 24 devices for WARSAW ORTHOPEDIC, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list WARSAW ORTHOPEDIC, INC.'s devices?
Among its 24 most recently registered devices, WARSAW ORTHOPEDIC, INC. has devices listed in FDA 510(k) (24 devices).
What risk classes do WARSAW ORTHOPEDIC, INC.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for WARSAW ORTHOPEDIC, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for WARSAW ORTHOPEDIC, INC.?
FDA recall records list 10 recalls initiated by WARSAW ORTHOPEDIC, INC., the most recent initiated on 20 Jun 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from WARSAW ORTHOPEDIC, INC. in the registry?
The most recently registered devices listed for WARSAW ORTHOPEDIC, INC. include CRADLE, HOSPITAL BED CLOTHING, INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI, SCHULTZ PHALANGEAL COMPONENT DRIVER and WARSAW ORTHOPEDIC I BONE PLATE.