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. Indications for use include Recalled by Synthes (USA) Products LLC Due to Certain lots of the Application Instrument for Sternal...
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: 267
Why Was This Recalled?
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
Where Was This Sold?
This product was distributed to 15 states: CA, CO, IL, KY, LA, MA, MI, NE, OH, OK, PA, TX, UT, WA, WI
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