Synthes (USA) Products LLC recalls 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Recall date
- October 3, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0643-2017
- FDA classification
- Class II
- Brand / firm
- Synthes (USA) Products LLC
- Sold / distributed
- Distributed Nationwide
Why it was recalled
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
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