Stryker Biotech
Country not established
- Devices
- 1
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Stryker Biotech makes
Stryker Biotech manufactures bone void fillers, which are used to fill gaps or defects in bone structures during surgical procedures. These products are designed to support bone healing and integration in orthopedic applications.
The company’s portfolio is regulated under Class II medical devices in the U.S., with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Name Bone Void Filler Ref K041421
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Stryker Biotech, the earliest on 2006-08-16 and the most recent on 2010-10-25. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 25 Oct 2010 Z-1727-2011 Unclassified (pre-2012) Terminated A change to the Preparation for Use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved
2008
- 24 Jun 2008 Z-2311-2008 Unclassified (pre-2012) Terminated Product Package Insert misprint-text offset
2006
- 16 Aug 2006 Z-0254-2007 Unclassified (pre-2012) Terminated Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.
Frequently asked questions
How many devices does Stryker Biotech have in the registry?
The registry currently lists 1 device for Stryker Biotech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Biotech's devices?
Among its 1 most recently registered device, Stryker Biotech has devices listed in FDA 510(k) (1 device).
What risk classes do Stryker Biotech's devices fall under?
Among its 1 most recently registered device, the classes recorded for Stryker Biotech's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Stryker Biotech?
FDA recall records list 3 recalls initiated by Stryker Biotech, the most recent initiated on 25 Oct 2010. 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 Stryker Biotech in the registry?
The most recently registered devices listed for Stryker Biotech include NAME BONE VOID FILLER.