Recall Z-2136-2014 ยท FZX Guide, Surgical, Instrument
X Spine Systems Inc
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.
| Date | Aug 1, 2014 (initiated Jul 11, 2014) |
| Status | Terminated |
| Reason | Revision B of the tissue shields of the device was 7 mm longer than the previous design. |
| Root cause | Employee error |
| Action | X-Spine systems contacted both customers via telephone and instructed to return the affected product back to X-Spine. All product has been recovered. The distributors have already returned the recalled product. No product was utilized in any surgical procedure. Immediate Action Taken: X-spine inventory was reviewed and two pieces of each size were recovered from finished inventory. The X-spine sales person returned the product. The distributor has returned the remaining product. The devices were recovered prior to use in any surgical procedure. For further questions please call (937) |
| Quantity | A total of 5-pieces of each part number distributed |
| Distribution | US Distribution including the states of FL and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.