Plus Orthopedics
Country not established
- Devices
- 42
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Plus Orthopedics makes
Plus Orthopedics manufactures modular knee and hip replacement components, including cemented and porous tibial parts, bipolar prostheses, acetabular cups, and uniconylar knee systems. Their portfolio includes custom modifications to existing nail systems and total hip replacement components, such as the PIGALILEO THR system.
The company’s devices are classified under FDA Class II and are authorised via the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 42 devicesFDA recalls
FDA recall records list 5 recalls initiated by Plus Orthopedics, the earliest on 2002-09-09 and the most recent on 2005-01-04. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, mechanical integrity, performance or accuracy 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
- 4 Jan 2005 Z-0540-05 Unclassified (pre-2012) Terminated Knee tibial insert is mislabeled completely as different device.
2004
- 10 Feb 2004 Z-0710-04 Unclassified (pre-2012) Terminated Ceramic femoral ball heads break.
2003
- 19 Sep 2003 Z-0339-04 Unclassified (pre-2012) Terminated Design Change
- 1 Aug 2003 Z-0107-04 Unclassified (pre-2012) Terminated Plastic insert over articular surface of knee joint replacement may become dislodged.
2002
- 9 Sep 2002 Z-0170-04 Unclassified (pre-2012) Terminated Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
Frequently asked questions
How many devices does Plus Orthopedics have in the registry?
The registry currently lists 42 devices for Plus Orthopedics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Plus Orthopedics's devices?
Among its 42 most recently registered devices, Plus Orthopedics has devices listed in FDA 510(k) (42 devices).
What risk classes do Plus Orthopedics's devices fall under?
Among its 42 most recently registered devices, the classes recorded for Plus Orthopedics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Plus Orthopedics?
FDA recall records list 5 recalls initiated by Plus Orthopedics, the most recent initiated on 2005-01-04. 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 Plus Orthopedics in the registry?
The most recently registered devices listed for Plus Orthopedics include RT-PLUS MODULAR CEMENTED KNEE COMPONENTS, PLUS BIPOLAR PROSTHESIS COCRMO, TC-PLUS POROUS TIBIAL COMPONENTS and MODIFICATION TO SLIM GLIDING NAIL SYSTEM.