FDA-Device2013-08-21Class II
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Synthes USA HQ, Inc.
Hazard
Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.
Sold states
Nationwide Distribution.
Affected count
13,050
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2013Don't want to check this manually?
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