FDA Device recall Z-0477-2014
Zimmer Trabecular Metal Total Ankle Tibial Base Component 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 Tibial Base Component 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-0477-2014 |
| 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 Tibial Base Component 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 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 004500…Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 0045000 |
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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-0477-2014%22
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