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.
Recall
- Recall Number
- Z-0649-2012
- Event Number
- 60225
- Firm
- Mani, Inc. Kiyohara Facility 8-3 Kiyohara Industrial Park Utsunomiya-shi, Tochigi-ken Japan
- FEI Number
- 3002692886
- Product Code
- GAM
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- July 20, 2011
- Posted
- January 11, 2012
- Terminated
- April 3, 2013
Description
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.
Surgical sutures may be weak and may not function as intended during surgical procedures.
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.
Nationwide Distribution -- PA and FL.
497 boxes