Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide Recalled by Synthes, Inc. Due to Certain affected parts and lots of the Pull...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes, Inc. directly.
Affected Products
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.
Quantity: 3747 US, 19 Foreign
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes, Inc.
Synthes, Inc. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report