Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implants
Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.
What this means for you
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, which typically corresponds to a High severity score (3) when no specific injuries or hospitalizations are reported in the source text, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 11 units of the AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. These medical devices are used in Total Knee Arthroplasty procedures. The recall was initiated because the affected products were over-molded, resulting in an outside diameter that did not conform to the specified print dimensions.
The affected devices were distributed nationwide to Indiana, Missouri, New York, and Texas. The specific units involved are identified by Model No. 150804 and Lot No. 088080 or 305410. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients who have received these specific implants should contact Zimmer Biomet for further instructions regarding the recall and potential replacement or corrective action.
The recalled product
- Product
- AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 11
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 (2)
- Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080)
- 305410 ((01)00880304240247(17)220601(10)305410).
Distribution
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.
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