CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

Tritanium TL Steerable Inserter recalled by Howmedica Osteonics

Howmedica Osteonics is recalling Tritanium TL Steerable Inserter, distributed nationwide in the US. The recall was initiated on 12 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled58

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0207-2019
FDA event ID: 81096
Recalling firm: Howmedica Osteonics, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 12 Sep 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Sterility
Device type: Other Medical Devices

Timeline

12 Sep 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+41 days
31 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Is Tritanium TL Steerable Inserter recalled?

Yes. Howmedica Osteonics recalled Tritanium TL Steerable Inserter on 12 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0207-2019.

Why was it recalled?

Which lots are affected?

All lots

Where was it sold?

US Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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