Recall Z-1146-2015— Biomet Spine, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Spine, LLC, initiated 2012-11-30, terminated 2015-05-22. It names one FDA 510(k) clearance: K122145. Product: 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.. Reason: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification.
- Recalling firm
- Biomet Spine, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-30
- Terminated
- 2015-05-22
- Firm location
- Broomfield, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Data sourced from openFDA. This site is unofficial and independent of the FDA.