Titan Spine Recalls TCS Straight Hexalobe Drivers Due to Tip Shearing
Titan Spine, LLC is recalling 26 Endo TCS Driver Straight Hexalobe #6 units because the tips sheared off during use in patients with dense bones.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device (tip shearing) that occurred during use, posing a significant risk of injury to patients, which aligns with the criteria for a Severe rating.
Plain-English summary
Titan Spine, LLC is recalling 26 units of the Endo TCS Driver Straight Hexalobe #6 (P/N 5210-1004), Lot # G150101. These non-sterile instruments are part of the surgical tray used with the Interbody Fusion Device (IBD).
The recall was initiated because the driver tips sheared off during use in procedures involving patients with dense bones. This malfunction poses a risk of injury to patients during surgery.
The affected products were distributed in the United States to the states of AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT, and WI. Healthcare facilities and users should stop using these specific drivers and contact Titan Spine, LLC for further instructions.
The recalled product
- Product
- Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
- Manufacturer
- TITAN SPINE, LLC
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- G150101
Distribution
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