Synthes (USA) Products LLC recalls Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

Recall date

May 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2138-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue