Zimmer Biomet, Inc.: AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

Is my product affected?

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

• UPC 00880304240230

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet, Inc. is recalling 28 units of AGC 2000 LP Patella devices (model number 150802), which are used in total knee replacement surgery. The devices were manufactured with an over-molding defect that caused the outside diameter to not meet the required print specifications.

The affected devices were distributed nationwide to Indiana, Missouri, New York, and Texas. The recall involves four specific lot numbers: 305330, 305340, 305350, and 356750, all manufactured in 2022. The source does not specify what consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Details from the source

Reason for recall: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. Distribution: US Nationwide Distribution to IN, MO, NY, TX. Quantity: 28 devices Lot/code info: Model No. 150802: Lot No. 305330 (UDI (01)00880304240230(17)220506(10)305330), 305340 ((01)00880304240230(17)220506(10)305330), 305350 ((01)00880304240230(17)220517(10)305350), 356750 ((01)00880304240230(17)220523(10)356750).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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