Use caution Medical device recall · FDA · Published September 12, 2018

Howmedica Tritanium TL Steerable Inserter Recall: Locking Mechanism Failure Risk

Howmedica recalls Tritanium TL Steerable Inserter (Cat. No. 48930000) due to locking mechanism failure that may cause implant misplacement during spinal surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0207-2019Medical device Howmedica ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmHowmedica Osteonics Corp.2 Pearl Ct · Allendale, NJ 07401-1611

✎ GovInfoNow plain-language explainer

Howmedica is recalling its Tritanium TL Steerable Inserter surgical device because the locking mechanism may not function properly, risking improper implant placement during spinal surgery. This could lead to the implant contacting sensitive anatomy or being placed in an incorrect position. Read more at govinfonow.com/recall/69877-howmedica-tritanium-tl-steerable-inserter-recall-locking-mechanism-failure-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69877-howmedica-tritanium-tl-steerable-inserter-recall-locking-mechanism-failure-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0207-2019

Cite this page

“Howmedica Tritanium TL Steerable Inserter Recall: Locking Mechanism Failure Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69877-howmedica-tritanium-tl-steerable-inserter-recall-locking-mechanism-failure-risk. Based on FDA recall #Z-0207-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0207-2019%22&limit=1).

The FDA announced on 2018-09-12 that Howmedica Osteonics Corp. is recalling the Tritanium TL Steerable Inserter due to a locking mechanism hazard. The agency classified the recall as Class II.

How to tell if you have it

Brand: Howmedica
Product: Tritanium TL Steerable Inserter
Cat. No.: 48930000
UDI: 07613327381900

The hazard

The firm received complaints that the locking mechanism on the steerable inserter was not functioning as intended due to a lack of lubrication. This issue may cause the implant to pivot unexpectedly, potentially contacting sensitive anatomy or resulting in suboptimal placement if the inserter fails to unlock.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since 2017-07-21. Other recent recalls of similar products include Howmedica OMNIFIT Series I Acetabular Insert Recall (2026-07-30), Howmedica Triathlon Baseplate Size 4 Recall (2026-05-19), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (2026-02-02). Other recent recalls of similar products include Medicrea IB3D Universal Implant Inserter Recall (2025-10-29), Medicrea IB3D PL Instruments Set Recall (2025-10-29), and Medline medical convenience kits recall (2026-02-27).

How to tell if you have this one

Check for the product model number 48930000 or unique device identifier 07613327381900 on the device packaging or label. This device is used in spinal surgery procedures.

Brand
Howmedica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the model number 48930000 or unique device identifier 07613327381900 on the device packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Sep 12, 2018Firm started the recall
Oct 23, 2018FDA classified it Class II
Oct 31, 2018Published in FDA’s Enforcement Report
Jul 16, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69877-howmedica-tritanium-tl-steerable-inserter-recall-locking-mechanism-failure-risk">Howmedica Tritanium TL Steerable Inserter Recall: Locking Mechanism Failure Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0207-2019 (September 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0207-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.