PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Company
- Ethicon, Inc. Us
- Recall Initiated
- August 8, 2022
- Recall Number
- Z-1773-2022
- Quantity
- 88 boxes (1056 ea)
- Firm Location
- Somerville, NJ
Reason for Recall
Product may contain the incorrect material which could impact treatment.
Distribution
Distribution in Japan only
Lot / Code Info
UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL
Root Cause
Process control
Action Taken
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 the recall letter instructions.