Synthes, Inc. recalls Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed throug

Recalled June 24, 2015 · FDA recall Z-1799-2015 · Synthes

Hazard

Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage. · FDA Class II

Units

3747 US, 19 Foreign

Sold at

Worldwide Distribution-US (nationwide) and internationlly to Canada

Description

Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.

Product

Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿), Translational adjustments, Stabilization of plate bone orientation during insertion of the first screws, alignment of segmental fragments and pre-drilling dense or thick cortical bone before placing a 5.0 mm locking screw.

Manufacturer(s)

Synthes, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →