Aliquot Delivery Kit — Class II medical device recall Z-2772-2015
Terminated recall by Orthovita, Inc., dBA Stryker Orthobiologics., reported 2015-09-23, distributed nationwide. Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging conf
| Recall number | Z-2772-2015 |
|---|---|
| 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 | 2015-08-20 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, DK, ES, FR, GB, IT, MT, NL, SE, TR, ZA |
| Quantity | 9,805 |
| Reason classes | sterility |
Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Reason for recall
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
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-2772-2015. 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.