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.
This recall has been terminated (originally issued August 1, 2014).
- Company
- X Spine Systems Inc
- Recall Initiated
- July 11, 2014
- Posted
- August 1, 2014
- Terminated
- August 14, 2014
- Recall Number
- Z-2136-2014
- Quantity
- A total of 5-pieces of each part number distributed
- Firm Location
- Miamisburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Distribution
US Distribution including the states of FL and MO.
Lot / Code Info
Part numbers X079-0096 and X079-0097 with Lot #12320
Root Cause
Employee error
Action Taken
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) 847-8410