Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2018
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
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 lubric…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Howmedica Osteonics Corp. recalled Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: … - a moderate-severity action.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: … was recalled by Howmedica Osteonics Corp. in October 31, 2018. Reason: The firm received complaints related to the locking mechanism on the steerable inserter not functioning as in…. Check the official notice for the remedy. Verify recall #Z-0207-2019 with the FDA Devices before acting.
The recall
Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-The firm received complaints related to the locking mechanism on the steerable inserter not functioning as in….
- Moderate
- severity level
- 58 units
- affected scope
- Class II
- classification
- October 31, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0207-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0207-2019) was formally reported on October 31, 2018, with the manufacturer initiating the action on September 12, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Allendale, NJ. Federal records list the affected scope as 58.
The documented reason for this recall is: 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 tw… Distribution data in the federal record shows the product reached: US Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
58
Related Recalls
6
3 from same agency
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0207-2019 |
| Date reported | October 31, 2018 |
| Date initiated | September 12, 2018 |
| Recalling firm | Howmedica Osteonics Corp. |
| Firm location | Allendale, NJ |
| Affected scope | 58 |
| Distribution | US Nationwide Distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0207-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Howmedica Osteonics Corp.. Units affected: 58.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0207-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0207-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 31, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.