Serrated Soft Tissue Shields — Class II medical device recall Z-2136-2014
Terminated recall by X Spine Systems Inc, reported 2014-08-13, distributed in FL, MO. Revision B of the tissue shields of the device was 7 mm longer than the previous design.
| Recall number | Z-2136-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X Spine Systems Inc, Miamisburg, OH, United States |
| Recall initiated | 2014-07-11 |
| Classified | 2014-08-01 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2014-08-14 |
| Distributed | FL, MO |
| Quantity | 5 |
| Lot numbers | 12320 |
| Model numbers | X079-0096, X079-0097 |
Product
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Reason for recall
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
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-2136-2014. 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.