Z-1773-2022 Class II Ongoing
FDA device recall Z-1773-2022 was initiated by Ethicon, Inc. on August 8, 2022 and is designated Class II. Reason for recall: Product may contain the incorrect material which could impact treatment. The recall status is ongoing. Affected quantity: 88 boxes (1056 ea).
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- August 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 boxes (1056 ea)
Product Description
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Reason for Recall
Product may contain the incorrect material which could impact treatment.
Distribution Pattern
Distribution in Japan only
Code Information
UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL