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

Recall Insight

This FDA Devices action (record #Z-1799-2015) was formally reported on June 24, 2015, with the manufacturer initiating the action on May 28, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records indicate 3747 US, 19 Foreign units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) and internationlly to Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.