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Terminated

Zimmer Trabecular Metal Total Ankle Talar Component Right 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.

FDA Recall Z-0476-2014 · Posted 2013-12-10

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeHSN
Date Initiated2013-11-12
Date Terminated2014-10-15
Product Quantity265 units (US) 114 units (outside US)

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

Firm Action

Zimmer sent an URGENT MEDICAL DEVICE RECALL notification letter dated November 12, 2013 to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to locate and remove the affected product from their inventory and notify their Zimmer representataive. The Zimmer representative will remove the recalled product from their facility. For patients that previously had the affected product implanted, consignees were instructed to continue their operative follow up routine. Consignees with questions were instructed to call 1-877-946-2761. For questions regarding this recall call 800-613-6131.

Root Cause

Manufacturing material removal

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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