Synthes (USA) Products LLC recalls Inserter for Titanium Elastic Nails (TEN), orthopedic device
- Recall date
- September 3, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0125-2016
- FDA classification
- Class II
- Brand / firm
- Synthes (USA) Products LLC
- Sold / distributed
- US (nationwide) distribution and one Internationally to Australia.
Why it was recalled
potential for mechanical failures such as breakage.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Inserter for Titanium Elastic Nails (TEN), orthopedic device
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