Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a pa

FDA device recall Z-0477-2014 · posted 2013-12-10 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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

Action taken

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

Status

Terminated

Product code

HSN

Quantity affected

390 units (US) 129 units (outside of US)

Distribution

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

Date initiated

2013-11-12

Date posted

2013-12-10

Date terminated

2014-10-15

Location

Warsaw, IN

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