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U.S. Department of Health and Human Services

Class 2 Device Recall MANI Needle and Suture Pack PGA Absorbable

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  Class 2 Device Recall MANI Needle and Suture Pack PGA Absorbable see related information
Date Initiated by Firm July 20, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on April 03, 2013
Recall Number Z-0649-2012
Recall Event ID 60225
510(K)Number K053636  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan***

For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Code Information Z098004000, Z098005600, Z098005700, Z098005900, Z098006700, and Z108003300.
Recalling Firm/
Manufacturer		 Mani, Inc. - Kiyohara Facility
8-3 Kiyohara Industrial Park
Utsunomiya-shi, Tochigi-ken Japan
Manufacturer Reason
for Recall		 Surgical sutures may be weak and may not function as intended during surgical procedures.
FDA Determined
Cause 2		 Component change control
Action The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list "Returned." If there was no product left, then the amount used should be placed in the list "Used." Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.
Quantity in Commerce 497 boxes
Distribution Nationwide Distribution -- PA and FL.
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 = GAM and Original Applicant = MANI, INC.
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