Recall Z-2534-2018— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2018-06-08, terminated 2020-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347). Reason: Products do not meet a tensile strength specification.
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-08
- Terminated
- 2020-09-25
- Firm location
- Somerville, NJ, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.