Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Application Instrument for Sternal ZIPFIX Recalled by Synthes (USA) Products LLC Due to The end cap may loosen and detach making...
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) Products LLC directly.
Affected Products
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Quantity: 451
Why Was This Recalled?
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes (USA) Products LLC
Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report