FDA Device recall Z-2136-2014
Serrated Soft Tissue Shields
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of Serrated Soft Tissue Shields by X Spine Systems, citing revision B of the tissue shields of the device was 7 mm longer than the previous design.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2136-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-11 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | X Spine Systems |
| Distribution | FL, MO |
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
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Identifiers
| code_info | Part numbers X079-0096 and X079-0097 with Lot #12320 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2014%22
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