CLASS III Device recall · Reported 10 May 2017 · FDA Enforcement Report
The TM Ardis Interbody System implant is a convex recalled
Zimmer Trabecular Metal Technology is recalling The TM Ardis Interbody System implant is a convex, straight Tlif or Plif device for, distributed nationwide in the US. The recall was initiated on 7 Jul 2016 and the FDA has classified it as Class III.
Recall details
- Recall number
- Z-1892-2017
- FDA event ID
- 76652
- Recalling firm
- Zimmer Trabecular Metal Technology, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jul 2016
- FDA classified
- 28 Apr 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Spinal Implants
Timeline
| 7 Jul 2016 | Recall initiated by company | |
| 28 Apr 2017 | Classified by FDA | +295 days |
| 10 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it 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.
Where was it sold?
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zimmer Trabecular Metal Technology
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NexGenTrabecular Metal Tibial Half Block Augment recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | NexGenTrabecular Metal Tibial Half Block Augment recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | Porous Patella - 00587806532 Porous Patella recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | 00720504022 Acetab.cupw/sh,0deg,22mmx40mm recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
| Device | CLASS II | Rev. Shell Liner 0d 00700504828 Rev. Shell Liner 10d recalled | Zimmer Trabecular Metal Technology | Foreign Material | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |