Device product
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Z-1773-2022
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 90764
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88 boxes (1056 ea)
- Official record key
device-enforcement:Z-1773-2022
Official wording
Reason: Product may contain the incorrect material which could impact treatment.
Code information: UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL
Distribution pattern: Distribution in Japan only
Derived failure modes
-
Unknown
Product may contain the incorrect material which could impact treatment.