CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle recalled
Orthovita Inc is recalling Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle, distributed nationwide in the US. The recall was initiated on 4 Dec 2014 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-0937-2015
- FDA event ID
- 69979
- Recalling firm
- Orthovita Inc, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Dec 2014
- FDA classified
- 7 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 4 Dec 2014 | Recall initiated by company | |
| 7 Jan 2015 | Classified by FDA | +34 days |
| 14 Jan 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
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Stryker 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 percutaneous (or deep) delivery of bone cement.
Where it was distributed
Worldwide Distribution: US (nationwide) and country of: Canada.
Questions about this recall
Why was it recalled?
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
Which lots are affected?
all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.: 2110-0505, 2110-0506, 2110-0524, 2110-0529.
Where was it sold?
Worldwide Distribution: US (nationwide) and country of: Canada.
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.
Other products in this recall event
1 other product · FDA event 69979| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle recalled | Orthovita Inc | Packaging Defects | Nationwide |
More recalls from Orthovita Inc
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aliquot Delivery Kit (Syringe and Plunger) recalled by Orthovita, Inc | Orthovita Inc | Sterility | Nationwide |
| 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 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 I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| 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 |