Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Recalled by Synthes, Inc. Due to May have difficulty attaching the drill sleeve to...
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
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Quantity: 567 units
Why Was This Recalled?
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Where Was This Sold?
Distribution to US, Canada, and Germany.
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