Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6… — Class II medical device recall Z-0477-2014
Terminated recall by Zimmer, Inc., reported 2013-12-18, distributed nationwide. As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Tala
| Recall number | Z-0477-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-11-12 |
| Classified | 2013-12-10 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, FI, IT |
| Lot numbers | 00450004100, 00450004200, 00450004300, 00450004400, 00450004500, 00450004600, 00830004100, 00830004200, 00830004300, 00830004400, 00830004500, 00830004600, 62143211, 62143212, 62143213, 62143215, 62143216, 62160229, 62168364, 62204736, 62204737, 62204738, 62204739, 62208152, 62208157, 62208158, 62208159, 62208160, 62215399, 62215401, 62215402, 62215403, 62215404, 62220681, 62220683, 62220684, 62220686, 62220688, 62226572, 62226573 and 82 more |
| Model numbers | 00450004100, 00450004200, 00450004300, 00450004400, 00450004500, 00450004600, 00830004100, 00830004200, 00830004300, 00830004400, 00830004500, 00830004600, 62143211, 62143212, 62143213, 62143215, 62143216, 62160229, 62168364, 62204736, 62204737, 62204738, 62204739, 62208152, 62208157 and 97 more |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0477-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.