Z-0207-2019Class II

Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900

Name: Z-0207-2019 Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900
Creator: Howmedica Osteonics Corp.
Published: 2018-09-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-09-12 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of 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... on 2018-09-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0207-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Posted: 2018-10-23
Terminated: 2020-07-16
Recalling firm: Howmedica Osteonics Corp
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
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Under Investigation by firm
Action: On September 12, 2018, the firm notified its sales personnel of the recall via a Product Correction letter. The letter identified the affected product, problem and actions to be taken. Applicable Stryker personnel that are involved in the maintenance or preparation of the Tritanium TL Inserter have been identified to receive notification of this correction to assure that the instrument is lubricated adequately.
Quantity in commerce: 58
Distribution: US Nationwide Distribution.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0207-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)