Reported Aug 1, 2018 · Terminated
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code:…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single
- Armed PS-6 Prime Needle Product CodeZ511G (GTIN 10705031061347)
- Lot codes and dates
- Lot NumberMCZ363
- Amount recalled
- 72
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Products do not meet a tensile strength specification
This product could cause temporary or reversible health problems — stop using it.
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