FDA Device recall Z-0475-2014
Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited m…
- 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 Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited m… 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-0475-2014 |
| 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 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.
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 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 004500…Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 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-0475-2014%22
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