Recall Register

Orthovita, Inc., dBA Stryker Orthobiologics.: FDA recalls

FDA enforcement reports name Orthovita, Inc., dBA Stryker Orthobiologics. as the recalling firm in 4 events. The events have 17 product records. The recalls started from 2012 to 2015. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

4 events, newest first.

FDA enforcement events of Orthovita, Inc., dBA Stryker Orthobiologics.
InitiatedProduct (first record)TypeClassRecordsStatus
20 Aug 2015Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished boneDeviceClass II1Terminated
26 Feb 2015Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.DeviceClass II1Terminated
4 Dec 2014Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct (or open) and…DeviceClass II2Terminated
10 Nov 2012Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished boneDeviceClass II13Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Orthovita, Inc., dBA Stryker Orthobiologics.: events for each product type
TypeEvents
Device4
Orthovita, Inc., dBA Stryker Orthobiologics.: events in each class
ClassEvents
Class II4
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Orthovita, Inc., dBA Stryker Orthobiologics., by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Orthovita, Inc., dBA Stryker Orthobiologics.: FDA recalls. https://recallregister.com/firm/orthovita-inc-dba-stryker-orthobiologics/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
PA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Orthovita, Inc., dBA Stryker Orthobiologics. have?
Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Orthovita, Inc., dBA Stryker Orthobiologics.?
FDA event 72054, which the firm started on 20 Aug 2015. The first product in the record is: Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
How many FDA recalls of Orthovita, Inc., dBA Stryker Orthobiologics. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.