Reported Jun 17, 2015 · Terminated
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft…
Gyrus Acmi, Incorporated
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: Gyrus Acmi, Incorporated · 136 Turnpike Road · Southborough, MA · 01772-2118
Is this the product you have?
- Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
- Lot codes and dates
- Lot numberJC929332
- Amount recalled
- 12,020 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential lack of sterility assurance.
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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