Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: Recalled by Biomet Spine, LLC Due to Biomet Spine LLC is recalling the Set Screw...
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 Biomet Spine, LLC directly.
Affected Products
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.
Quantity: 1999
Why Was This Recalled?
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biomet Spine, LLC
Biomet Spine, LLC has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report