Z-2753-2011

Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 &...

Name: Z-2753-2011 Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 &...
Creator: Kapp Surgical Instrument Inc
Published: 2011-05-24
License: https://open.fda.gov/license/

Kapp Surgical GmbH / initiated 2011-05-24 / Terminated / root cause: labeling and UDI

FDA source

Kapp Surgical Instrument Inc began a recall of 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... on 2011-05-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2753-2011
Status: Terminated
Initiated: 2011-05-24
Posted: 2011-07-07
Terminated: 2013-02-19
Recalling firm: Kapp Surgical GmbH
Product: 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.
Product code: NEU Marker, Radiographic, Implantable
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 222 units (rings)
Distribution: Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.
Product codes and lots: M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.

Product code NEU

K072216Class IIKapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. / cleared 2007-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)