[Recalled] Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the instrument. There are two potential hazards associated with the implant pivoting unexpectedly during implant insertion into the disc space. First, if the implant is initially inserted into the disc space via the impaction method and the implant pivots unexpectedly, the implant potentially may unintentionally contact sensitive anatomy. Additionally, the user may potentially experience difficulty positioning the implant within the disc space due to the lack of rigidity. A third potential hazard is associated with the inserter not unlocking at the articulating pivot head during implant positioning within the disc space. Once the implant is in the prepared disc space and contacts the ventral annulus, the surgeon unlocks the articulating pivot head and positions the implant perpendicular to the spinous process. The surgeon may then elect to lock/unlock the articulating pivot head for desired final positioning of the implant. If the inserter does not unlock during these final implant positioning steps, the user may potentially implant the cage in a suboptimal trajectory/placement.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.