Orthovita, Inc., dBA Stryker Orthobiologics.
Complete recall history across all FDA and CPSC categories — 17 total recalls
Orthovita, Inc., dBA Stryker Orthobiologics. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (17)
FDA medical device enforcement actions by Orthovita, Inc., dBA Stryker Orthobiologics.
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 20, 2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous ... | Two isolated instances of holes in the outer header bag component of the doub... | Class II |
| Feb 26, 2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and op... | Several shipments of Vitagel product (a surgical hemostat) required to be sto... | Class II |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... | There is the potential for a breach in the inner or outer packaging pouches o... | Class II |
| Dec 4, 2014 | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... | There is the potential for a breach in the inner or outer packaging pouches o... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
| Nov 10, 2012 | Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - A... | There have been a few reported cases of the catheter breaking when removing t... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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