Reported Apr 8, 2020 · Terminated
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant…
Trilliant Surgical, LLC
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: Trilliant Surgical, LLC · 727 N Shepherd Dr Ste 100 · Houston, TX · 77007-1320
Is this the product you have?
- Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
- Lot codes and dates
- IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
- Amount recalled
- 4 systems total for both Twist Sublatar and Disco Sublatar
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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