Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle — Class II medical device recall Z-0938-2015
Terminated recall by Orthovita, Inc., dBA Stryker Orthobiologics., reported 2015-01-14, distributed nationwide. There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Mar
| Recall number | Z-0938-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthovita, Inc., dBA Stryker Orthobiologics., Malvern, PA, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2015-01-07 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 89,770 |
| Model numbers | 2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0938-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.