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 ind
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. recalled Zimmer Trabecular Metal Total Ankle Talar Components (left sizes 1-6) after discovering that Tibial Base and Talar Components potentially contained elevated levels of manufacturing residue on the implants. The residue consisted of mass media material used during the manufacturing process to create a uniform surface finish. A total of 269 units were distributed in the United States and 110 units were distributed internationally to Australia, Canada, China, Finland, Germany, and Italy.
The affected components are identified by part number 00450001100, 00450001200, 00450001300, and 00450001600 with multiple lot numbers listed in the recall documentation. The product recall record does not specify what action an affected consumer 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: 269 units (US) 110 units (outside US) Lot/code info: Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 00450001200 62290833 00450001200 62290835 00450001200 62372414 00450001200 62375863 00450001200 62397414 00450001200 62405304 00450001200 62416035 00450001200 62419530 00450001200 62430804 00450001300 62160227 00450001300 62163379 00450001300 62215393 00450001300 62264834 00450001300 62267628 00450001300 62267629 00450001300 62279045 00450001300 62279051 00450001300 62285548 00450001300 62290836 00450001300 62299551 00450001300 62331811 00450001300 62337756 00450001300 62349856 00450001300 62349857 00450001300 62368383 00450001300 62375865 0045000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.