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U.S. Department of Health and Human Services

Class 2 Device Recall Bariatric Target Ring (Nitinol)

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  Class 2 Device Recall Bariatric Target Ring (Nitinol) see related information
Date Initiated by Firm May 24, 2011
Date Posted July 07, 2011
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-2753-2011
Recall Event ID 59024
510(K)Number K072216  
Product Classification Marker, radiographic, implantable - Product Code NEU
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.
Code Information M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.
Recalling Firm/
Manufacturer		 Kapp Surgical Instrument Inc
4919 Warrensville Center Rd
Warrensville Heights OH 44128-4353
For Additional Information Contact
216-587-4400
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NEU and Original Applicant = KAPP SURGICAL INSTRUMENT, INC.
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