Zimmer Biomet AGC 2000 LP Patella Recall: Over-molded Product
Zimmer Biomet recalls AGC 2000 LP Patella implants (Model 150802) due to over-molding causing nonconforming outside diameter. This may affect surgical fit in total knee replacements.
Lower-risk recall
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling certain AGC 2000 LP Patella implants for total knee replacements. The implants were over-molded, which could cause the outside diameter to be nonconforming to the print dimension. This might affect surgical fit during knee replacement procedures. Read more at govinfonow.com/recall/73116-zimmer-biomet-agc-2000-lp-patella-recall-over-molded-product.
Source Summary by GovInfoNow · govinfonow.com/recall/73116-zimmer-biomet-agc-2000-lp-patella-recall-over-molded-product · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0627-2018
Cite this page
“Zimmer Biomet AGC 2000 LP Patella Recall: Over-molded Product.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73116-zimmer-biomet-agc-2000-lp-patella-recall-over-molded-product. Based on FDA recall #Z-0627-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0627-2018%22&limit=1).
Why it’s dangerous
The implants were over-molded, meaning the outside diameter does not match the printed specifications. This could lead to improper surgical fit during knee replacement procedures, potentially affecting the implant's performance.
Who’s affected
Patients who received the AGC 2000 LP Patella implant (Model 150802) for total knee replacement surgery are affected. Surgeons and medical facilities that used these specific implants during procedures are most at risk.
How to tell if you have this one
Check for the model number 150802 on the implant packaging. The specific lot numbers 305330, 305340, 305350, and 356750 are also associated with this recall.
- Brand
Zimmer Biomet- Product
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution to IN, MO, NY, TX.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0627-2018 | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.; 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). | 28 devices |
| Z-0628-2018 | AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.; Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410). | 11 devices |
What to do — step by step
Check Implant Details
Review the model number and lot numbers on the implant packaging to confirm if it is part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide Distribution to IN, MO, NY, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Indiana, Missouri, New York, Texas.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this implant?
No action is required for the implant itself as it is a surgical implant. The recall is for identification and potential replacement if needed.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0627-2018 (August 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0627-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.