Recall Z-0477-2014— Zimmer, Inc.

Name: FDA recall Z-0477-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-12

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-11-12, terminated 2014-10-15. It names one FDA 510(k) clearance: K120906. 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.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Terminated: 2014-10-15
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K120906 — ZIMMER TRABECULAR METAL TOTAL ANKLEZimmer, Inc.·cleared 2012-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.