Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b)… — Class II medical device recall Z-0874-2015
Terminated recall by Ebi, Llc, reported 2014-12-31, distributed nationwide. A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments
| Recall number | Z-0874-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ebi, Llc, Parsippany, NJ, United States |
| Recall initiated | 2014-11-11 |
| Classified | 2014-12-24 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 193 units |
| Lot numbers | 14-531593, 14-531594, N23597, N23599 |
| Model numbers | 14-531593, 14-531594, N23597, N23599 |
Product
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Reason for recall
A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
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-0874-2015. 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.