Z-1334-2020 Class II Terminated
FDA device recall Z-1334-2020 was initiated by Ethicon, Inc. on August 28, 2019 and is designated Class II. Reason for recall: The product do not meet certain internal testing specifications. The recall status is terminated (terminated February 11, 2021). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- August 28, 2019
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201
Reason for Recall
The product do not meet certain internal testing specifications.
Distribution Pattern
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Code Information
GTIN: 10705031235861 Lot Number: PAH360 Expiration Date: 12/31/2020