FDA-Device2013-04-17Class II
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Synthes USA HQ, Inc.
Hazard
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
Sold states
Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.
Affected count
328
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1062-2013Don't want to check this manually?
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