Z-2534-2018 Class II Terminated
FDA device recall Z-2534-2018 was initiated by Ethicon, Inc. on Jun 8, 2018 and is designated Class II. Reason for recall: Products do not meet a tensile strength specification The recall status is terminated (terminated Sep 25, 2020). Affected quantity: 72.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- Jun 8, 2018
- Termination Date
- Sep 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
Product Description
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
Reason for Recall
Products do not meet a tensile strength specification
Distribution Pattern
Japan
Code Information
Lot Number: MCZ363
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2534-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026