Recall Z-0650-2012 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Mani, Inc. - Kiyohara Facility
MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 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
| Date | Jan 11, 2012 (initiated Jul 20, 2011) |
| Status | Terminated |
| Reason | Surgical sutures may be weak and may not function as intended during surgical procedures. |
| Root cause | 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 | 497 boxes |
| Distribution | Nationwide Distribution -- PA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) Mani, Inc., Mar 14, 2006 |