Stryker Orthobiologics Aliquot Delivery System Manual Surgical… — Class II medical device recall Z-1398-2013
Terminated recall by Orthovita, Inc., dBA Stryker Orthobiologics., reported 2013-06-05, distributed nationwide. There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the need
| Recall number | Z-1398-2013 |
|---|---|
| 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 | 2012-11-10 |
| Classified | 2013-05-24 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-10-29 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| Lot numbers | E909009R |
| Model numbers | 2110-0524 |
Product
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
Reason for recall
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
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-1398-2013. 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.