Wright Medical Technology, Inc. recalls Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
- Recall date
- November 8, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0568-2020
- FDA classification
- Class II
- Brand / firm
- Wright Medical Technology, Inc.
- Sold / distributed
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Why it was recalled
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
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