Orthopedic Alliance, LLC
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 10
At a glance
Market reach
- United States
- FDA recalls
What Orthopedic Alliance, LLC makes
Orthopedic Alliance, LLC manufactures ceramic ball heads for shoulder implants, a total hip replacement system, and spinal fixation devices for the spine. These products are designed for joint arthroplasty and spinal stabilization procedures.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The products are listed in the FDA’s 510(k) database, reflecting their authorised status for the US market.
Catalogue
Sc Ceramic Ball Heads Ref K052237
Regimes: 510(k) Registry: 510(k)Sc Total Hip System Ref K031474
Regimes: 510(k) Registry: 510(k)Orthopedic Alliance Spine System Ref K033826
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 10 recalls initiated by Orthopedic Alliance, LLC, the earliest on 2013-02-20 and the most recent on 2013-03-07. By recorded status: 10 terminated. The reasons filed fall into these groups: sterility or contamination and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 7 Mar 2013 Z-1156-2013 Class II Terminated Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
- 20 Feb 2013 Z-1378-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1379-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1380-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1381-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1382-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1383-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1384-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1385-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- 20 Feb 2013 Z-1386-2013 Class II Terminated The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Frequently asked questions
How many devices does Orthopedic Alliance, LLC have in the registry?
The registry currently lists 3 devices for Orthopedic Alliance, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthopedic Alliance, LLC's devices?
Among its 3 most recently registered devices, Orthopedic Alliance, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Orthopedic Alliance, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Orthopedic Alliance, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthopedic Alliance, LLC?
FDA recall records list 10 recalls initiated by Orthopedic Alliance, LLC, the most recent initiated on 7 Mar 2013. 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 Orthopedic Alliance, LLC in the registry?
The most recently registered devices listed for Orthopedic Alliance, LLC include SC CERAMIC BALL HEADS, SC TOTAL HIP SYSTEM and ORTHOPEDIC ALLIANCE SPINE SYSTEM.