CLASS II Device recall · Reported 23 Sep 2015 · FDA Enforcement Report
Aliquot Delivery Kit (Syringe and Plunger) recalled by Orthovita, Inc
Orthovita Inc is recalling Aliquot Delivery Kit (Syringe and Plunger), distributed nationwide in the US. The recall was initiated on 20 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2772-2015
- FDA event ID
- 72054
- Recalling firm
- Orthovita Inc, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2015
- FDA classified
- 16 Sep 2015
- Reported
- 23 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 20 Aug 2015 | Recall initiated by company | |
| 16 Sep 2015 | Classified by FDA | +27 days |
| 23 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Where it was distributed
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Questions about this recall
Why was it recalled?
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Which lots are affected?
All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
Where was it sold?
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orthovita Inc
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vitagel; indicated in surgical procedures (other than recalled | Orthovita Inc | Other | Nationwide |
| Device | CLASS II | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle recalled | Orthovita Inc | Packaging Defects | Nationwide |
| Device | CLASS II | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle recalled | Orthovita Inc | Packaging Defects | Nationwide |
| Device | CLASS II | Stryker Orthobiologics Aliquot Delivery System Manual recalled | Orthovita Inc | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Orthobiologics Aliquot Delivery System Manual recalled | Orthovita Inc | Device Malfunction | Nationwide |
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| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |