🔍 RecallPedia

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Class I - Dangerous
🏥 Medical Devices Recalled: November 30, 2012 Biomet Spine Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    LOT Numbers: L561968 and L570545 Product Code: 77031600
  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:
Biomet Spine, LLC
Reason for Recall:
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

Product Codes/Lot Numbers:

LOT Numbers: L561968 and L570545 Product Code: 77031600

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1146-2015

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Biomet Spine

Class I - Dangerous

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