Reported Apr 3, 2019 · Terminated
Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number:…
Avitus Orthopaedics, 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: Avitus Orthopaedics, Inc. · 400 Farmington Ave Ste 2826 · Farmington, CT · 06032-1913
Is this the product you have?
- Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous
- bone and bone marrow Catalog NumberBH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
- Lot codes and dates
Lot Number/Exp. Date Z2458287A 2018-06-01Z2458379A 2018-10-01
- Amount recalled
- 207 units
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
Why it was recalled
Breach in the sterile barrier pouch may compromise sterility of the device.
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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