FDA-Device2016-07-13Class II
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Synthes (USA) Products LLC
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.
Sold states
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
Affected count
6,255 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2016Don't want to check this manually?
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