The TM Ardis Interbody System Inserter Stainless Steel — Class II medical device recall Z-0659-2013
Terminated recall by Zimmer, Inc., reported 2013-01-16, distributed nationwide. Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inse
| Recall number | Z-0659-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2013-01-09 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2014-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | SE |
| Quantity | 170 |
| Lot numbers | 61946711, 61946712, 61991588, 62000412 |
| Model numbers | 96-701-10001 |
Product
The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.
Reason for recall
Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0659-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.