Reported Oct 31, 2018 · Terminated
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | TL Steerable Inserter |
| 2 | TL Steerable Inserter Inner Shaft |
| 3 | TL Steerable Inserter Driver |
- Lot codes and dates
- All lots
- Amount recalled
- 58
Where it was sold
- Nationwide
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
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