FDA Device recall Z-0476-2014
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited…
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited… by Zimmer, citing 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 contai….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0476-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-12 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Zimmer Trabecular Metal Total Ankle Talar Component Right 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.
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
Identifiers
| code_info | Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 004500…Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 0045000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.