Class I — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks |
| Product | Zimmer Spine Ardis Inserter, Rx, non-sterile |
| Quantity | 315 (172 in USA) |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AR, AZ, CA, CO, CT, DC, FL, GA, ID, LA, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WI, and WV; and countries of: Australia, El Salvador, France and Singapore. |
| Initiated | 2012-11-12 |
| Classified | 2012-12-21 |
| Terminated | 2014-02-25 |
| Recall number | Z-0594-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Zimmer, Inc. (Z-0594-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63683/
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