Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle-… — Class II medical device recall Z-0937-2015
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 Stryker Orthobi
| Recall number | Z-0937-2015 |
|---|---|
| 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 | 2,155 |
| Model numbers | 2110-0505, 2110-0506, 2110-0524, 2110-0529 |
Product
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.
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.
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-0937-2015. 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.