Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported May 10, 2017
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instru
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Inform…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Trabecular Metal Technology, Inc. recalled The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for inter… - a low-severity action.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for inter… was recalled by Zimmer Trabecular Metal Technology, Inc. in May 10, 2017. Reason: This field action is being initiated following the firm's discovery of a procedural error in the approval of …. Check the official notice for the remedy. Verify recall #Z-1892-2017 with the FDA Devices before acting.
The recall
Zimmer Trabecular Metal Technology, Inc. issued this low-severity FDA Devices recall-This field action is being initiated following the firm's discovery of a procedural error in the approval of ….
- Low
- severity level
- 299 units
- affected scope
- Class III
- classification
- May 10, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1892-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1892-2017) was formally reported on May 10, 2017, with the manufacturer initiating the action on July 7, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Zimmer Trabecular Metal Technology, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 299 units; 200 brochures.
The documented reason for this recall is: This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors a… Distribution data in the federal record shows the product reached: 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
299 units; 200 brochures
Related Recalls
6
3 from same agency
Product description
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Reason for recall
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1892-2017 |
| Date reported | May 10, 2017 |
| Date initiated | July 7, 2016 |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 299 units; 200 brochures |
| Distribution | 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-1892-2017) 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? ▼
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.. Recalled by Zimmer Trabecular Metal Technology, Inc.. Units affected: 299 units; 200 brochures.
Why was this product recalled? ▼
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2017. Severity: Low. Recall number: Z-1892-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1892-2017) 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 May 10, 2017. 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.