Z-1339-2018 Class II Terminated
FDA device recall Z-1339-2018 was initiated by Ethicon, Inc. on Jan 10, 2018 and is designated Class II. Reason for recall: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date… The recall status is terminated (terminated Apr 11, 2019). Affected quantity: 72.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Jan 10, 2018
- Termination Date
- Apr 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72
Product Description
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Reason for Recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Distribution Pattern
Distribution US Nationwide, Canada, India, and Colombia.
Code Information
Product code: PDP695H GTIN: 10705031048584 Product lot: LL6590
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1339-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026