# FDA recall Z-0207-2019

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2018-09-12.

## Product

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 space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver

## Reason for recall

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 t

## Distribution

US Nationwide Distribution.

## Key facts

- **Recall number:** Z-0207-2019
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-12
- **Report date:** 2018-10-31
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allendale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0207-2019

## Citation

> AI Analytics. FDA recall Z-0207-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0207-2019. Source: US FDA. Licensed CC0.

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