PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 24, 2015 Initiated: May 28, 2015 #Z-1799-2015

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Synthes, Inc.
Units Affected
3747 US, 19 Foreign
Distribution
Worldwide Distribution-US (nationwide) and internationlly to Canada
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Synthes, Inc.. Units affected: 3747 US, 19 Foreign.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Moderate. Recall number: Z-1799-2015.

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