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 in
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. recalled Zimmer Trabecular Metal Total Ankle Talar Components in right sizes 1-6 due to the discovery of elevated levels of manufacturing materials residue on the implants. During routine manufacturing process monitoring, the company found that mass media used to create a uniform surface finish on the Tibial Base and Talar Components was not adequately removed. The recalled products were distributed worldwide, including throughout the United States and to Australia, Canada, China, Finland, Germany, and Italy, with 265 units distributed in the U.S. and 114 units distributed internationally.
The recall affects implants with multiple lot numbers associated with part numbers 00450002100, 00450002200, 00450002300, 00450002500, and 00450002600. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy. Quantity: 265 units (US) 114 units (outside US) Lot/code info: Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 0045000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.