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Synthes USA HQ, Inc. recalls Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Recalled August 21, 2013 · FDA recall Z-1952-2013 · Synthes USA HQ
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. · FDA Class II
Units
13,050
Sold at
Nationwide Distribution.
Description
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.
Product
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →