Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body Recalled by Synthes USA HQ, Inc. Due to This action is being initiated following a detailed...
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 USA HQ, Inc. directly.
Affected Products
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Quantity: 757
Why Was This Recalled?
This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes USA HQ, Inc.
Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report