FDA-Device2016-04-06Class II
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Synthes (USA) Products LLC
Hazard
DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi
Sold states
Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Affected count
42 plate systems
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2016Don't want to check this manually?
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