Recall Z-1773-2022 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
| Date | Aug 8, 2022 |
| Status | Open, Classified |
| Reason | Product may contain the incorrect material which could impact treatment. |
| Root cause | Process control |
| Action | Customer notification began August 8, 2022. The responsible Johnson & Johnson affiliates in Japan will be contacting all their impacted primary and secondary consignees and/or end customers. Customers are asked to immediately check inventory for impacted product and to quarantine that product. In the event product has been forwarded to another facility, the customer shall contact that facility to arrange return. The customer shall complete the Business Reply Form (BRF) to confirm receipt of the recall notice within 3 business days. Customers are required to return unused impacted product per |
| Quantity | 88 boxes (1056 ea) |
| Distribution | Distribution in Japan only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.