CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle recalled
Orthovita Inc is recalling Stryker Orthobiologics Imbibe Bone Marrow Aspiration 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-0938-2015
- 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 Imbibe Bone Marrow Aspiration 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 Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch intended for use to aspirate bone marrow or autologous blood.
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 Imbibe Bone Marrow Aspiration Needle.
Which lots are affected?
all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.: 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047
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 69979This product is part of a recall event; the main page for the event is Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement 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 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 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 |