May 01, 2015
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DePuy Synthes issues medical device field safety notice for pedicle awl technique guide
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A medical device field safety notice has been issued by DePuy Synthes for the technique guides of the Pangea, USS II Polyaxial, Matrix Deformity and Matrix Degenerative spine systems, and for the outer labels for two pedicle awls.
According to the notice, the technique guides for the four systems describe the pedicle awls as 4 mm for use with 4-mm to 7-mm screws. The awls should be used with 5-mm to 7-mm screws. The notice was issued to communicate the changes made to the technique guides and the outer labels to clarify the correct screws that should be used with the system.
There has been no change to the design or manufacture of the pedicle awls, according to the medical device field safety notice.
Reference: www.depuysynthes.com.