FDA Medical Device Recalls (openFDA)
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 during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.
- Recall number
- Z-2753-2011
- Recalling firm
- Kapp Surgical Instrument Inc
- 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.
- Status
- Terminated
- Initiated
- 2011-05-24
- Posted
- 2011-07-07
- Terminated
- 2013-02-19
- 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.
- Lot, serial or model codes
- M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.
- 510(k) numbers
- ["K072216"]
- PMA numbers
- not on file
- Product code
- NEU
- Firm FEI
- 1522875
- Firm city
- Warrensville Heights
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28