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Synthes (USA) Products LLC recalls Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Recalled July 13, 2016 · FDA recall Z-2138-2016 · Synthes (USA) Products
Hazard
DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard. · FDA Class II
Units
6,255 units
Sold at
USA Distribution to the states of : AK,AL,AR,AZ,CA,CH,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,ON,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI, & WV
Description
DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.
Product
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →