MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pa
FDA device recall Z-0650-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Mani, Inc. - Kiyohara Facility
- Reason for recall
- Surgical sutures may be weak and may not function as intended during surgical procedures.
- Action taken
- 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
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 497 boxes
- Distribution
- Nationwide Distribution -- PA and FL.
- Date initiated
- 2011-07-20
- Date posted
- 2012-01-11
- Date terminated
- 2013-04-03
- Location
- Utsunomiya-shi, Tochigi-ken, Japan
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) (K053636) | Mani, Inc. | 2006-03-14 |