Recall Z-0475-2014 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Zimmer, Inc.
Zimmer Trabecular Metal Total Ankle Talar Component Left 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
| Date | Dec 10, 2013 (initiated Nov 12, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Manufacturing material removal |
| 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 t |
| Quantity | 269 units (US) 110 units (outside US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE Zimmer, Inc., Aug 24, 2012 |