Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Application Instrument Sternal Zip Flex System intended for use Recalled by Synthes USA HQ, Inc. Due to When using the 1st generation Zip Fix Application...
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 Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Quantity: 319
Why Was This Recalled?
When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
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