Class II — 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 II |
| Status | Terminated |
| Reason | As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. This mass media |
| Product | Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only. |
| Quantity | 269 units (US) 110 units (outside US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy. |
| Initiated | 2013-11-12 |
| Classified | 2013-12-10 |
| Terminated | 2014-10-15 |
| Recall number | Z-0475-2014 |
| 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 II recall — Zimmer, Inc. (Z-0475-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66717/
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