Retiro De Equipo (Recall) de Device Recall ZeroP StarDrive Screwdriver Shaft

Recall

51781

Class 2

Z-1348-2009

2009-02-10

2009-06-10

Terminated

United States

2009-10-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81257

Tip breakage, due to inadequate instructions for use. the technique guide provided incorrect information related to use of the torque limiting attachment during screw insertion and final tightening.

All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.