Device Recall Bariatric Target Ring (Nitinol)

M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.

General and Plastic Surgery Devices

2

Yes

Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.

Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. || It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.