Z-0653-2012

MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual...

Name: Z-0653-2012 MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual...
Creator: Mani, Inc. - Kiyohara Facility
Published: 2011-07-20
License: https://open.fda.gov/license/

Mani, Inc. (Head Office) / initiated 2011-07-20 / Terminated

FDA source

Mani, Inc. - Kiyohara Facility began a recall of MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages... on 2011-07-20. The reason FDA records is "Surgical sutures may be weak and may not function as intended during surgical procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0653-2012
Status: Terminated
Initiated: 2011-07-20
Posted: 2012-01-11
Terminated: 2013-04-03
Recalling firm: Mani, Inc. (Head Office)
Product: MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 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.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Surgical sutures may be weak and may not function as intended during surgical procedures.
FDA 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 in commerce: 497 boxes
Distribution: Nationwide Distribution -- PA and FL.
Product codes and lots: Z108001100, Z108005300

Product code GAM

K053636Class IIMani Needle & Suture Pack (Pga Absorbable)Mani, Inc. / cleared 2006-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)