Recall Z-2753-2011 ยท NEU Marker, Radiographic, Implantable
Kapp Surgical Instrument Inc
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
| Date | Jul 7, 2011 (initiated May 24, 2011) |
| Status | Terminated |
| Reason | During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp Surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped. |
| Root cause | Labeling mix-ups |
| Action | Kapp Surgical Instrument, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical. Questions about this recall are directed to the QA Manager at 800-282-5277. |
| Quantity | 222 units (rings) |
| Distribution | Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 Kapp Surgical Instrument, Inc., Nov 9, 2007 |