Recall Z-2534-2018 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
| 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 | 72 |
| Distribution | Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.