Recall Z-2533-2018 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
| Date | Jun 8, 2018 |
| Status | Terminated |
| Reason | Products do not meet a tensile strength specification |
| Root cause | Under Investigation by firm |
| Action | Johnson & Johnson Affiliate Japan notified consignees on 6/08/18 by customer letter through post or email or sales representative visits. Accounts requested to Examine inventory, remove and quarantine such product(s) and complete the Business Reply Form (BRF). Product to requested to be returned. |
| Quantity | 756 |
| Distribution | Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061037 | PDS PLUS ANTIBACTERIAL SUTURE ETHICON, Inc., Jul 14, 2006 |