PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
Reported: August 1, 2018 Initiated: June 8, 2018 #Z-2534-2018
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
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 72
- Distribution
- Japan
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347). Recalled by Ethicon, Inc.. Units affected: 72.
Why was this product recalled? ▼
Products do not meet a tensile strength specification
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2534-2018.
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