The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0627-2018·Announced 2018-02-21

Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implant Devices

Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural nonconformance in a medical device used for joint replacement, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Zimmer Biomet, Inc. is recalling 28 units of the AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. These medical devices are intended for use in Total Knee Arthroplasty.

The recall was initiated because the affected products were over-molded, which resulted in the outside diameter being nonconforming to the specified print dimension. The agency has classified this recall as Class II.

The devices were distributed nationwide to Indiana, Missouri, New York, and Texas. Specific lot numbers involved include 305330, 305340, 305350, and 356750. Patients who have had these specific devices implanted should contact their healthcare provider for evaluation and guidance.

The recalled product

Product
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 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).

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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