MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 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.
FDA Recall Z-0654-2012 · Posted 2012-01-11
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Recalling FirmMani, Inc. - Kiyohara Facility
Recall StatusTerminated
Product CodeGAM
Date Initiated2011-07-20
Date Terminated2013-04-03
Product Quantity497 boxes
Reason for Recall
Surgical sutures may be weak and may not function as intended during surgical procedures.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Nationwide Distribution -- PA and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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