Stryker Orthobiologics
Country not established
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Stryker Orthobiologics makes
Stryker Orthobiologics manufactures synthetic, non-antimicrobial bone matrix implants designed for injectable use in orthopedic procedures. These products are formulated to support bone regeneration and structural integrity in surgical applications.
The company’s portfolio is classified under FDA’s Class II medical devices and is registered in the FDA’s Unique Device Identifier (UDI) database. The products are developed and distributed from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 849227939
- [email protected]
- Phone
- +1(610)640-1775
FDA recalls
FDA recall records list 1 recall initiated by Stryker Orthobiologics, initiated on 2012-07-26. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 26 Jul 2012 Z-0431-2013 Class II Terminated When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
Full distribution text
- 26 Jul 2012 Z-0431-2013 Class II Terminated When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
Frequently asked questions
How many devices does Stryker Orthobiologics have in the registry?
The registry currently lists 5 devices for Stryker Orthobiologics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Orthobiologics's devices?
Among its 5 most recently registered devices, Stryker Orthobiologics has devices listed in FDA GUDID (5 devices).
What risk classes do Stryker Orthobiologics's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Stryker Orthobiologics's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Stryker Orthobiologics?
FDA recall records list 1 recall initiated by Stryker Orthobiologics, the most recent initiated on 26 Jul 2012. 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 Orthobiologics in the registry?
The most recently registered devices listed for Stryker Orthobiologics include Vitoss BA Injectable 2102-2305, Vitagel 2113-0002, Vitoss BA Injectable 2102-2302 and Vitagel 2113-0003.