Serrated Soft Tissue Shields. Orthopedic surgical recall
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical…
Why was Serrated Soft Tissue Shields. Orthopedic surgical recalled?
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part numbers X079-0096 and X079-0097 with Lot #12320
- Product
- Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical…
- Recalling firm
- X Spine Systems Inc
- Quantity
- A total of 5-pieces of each part number distributed
- Distribution
- US Distribution including the states of FL and MO.
- Recall date
- August 13, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)