🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2013 Synthes USA HQ Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Synthes USA HQ, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0114-2014

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