Reported Dec 18, 2013 · Terminated
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- 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
- Lot codes and dates
- Part Number Lot Number
220 of 220 codes
004500041006214321100450004100622153990045000410062226572004500041006223979700450004100622488080045000410062285639004500041006229085300450004200621432120045000420062208157004500042006220815800450004200622154010045000420062220683004500042006222657300450004200622488090045000420062267650004500042006228555400450004200622995450045000420062393808004500042006241604800450004200624195410045000430062143213004500043006216022900450004300622081590045000430062215402004500043006222068100450004300622206840045000430062267645004500043006227905700450004300622855550045000430062285556
- Part Number Lot Number
- Amount recalled
- 390 units (US) 129 units (outside of US)
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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