BIOMET PATELLAR SYSTEM recallZ-0628-2018 · Zimmer Biomet, Inc. · initiated Aug 25, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
FDA root cause category: Process change control
What the company is doing
Consignees were notified via mail on approximately 08/25/2017. Instructions to distributors, sales representatives, and distributor operations managers include to ensure affected team members are aware of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide any additional hospitals and/or surgeons that received direct shipments. Instructions to risk managers and surgeons include to ensure affected personnel are informed of the recall, quarantine all affected product, return any affected product in inventory, and complete and return the Certificate of Acknowledgment. Questions or concerns can be sent to the Zimmer Biomet customer call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday. Or they can be sent via email to [email protected].
Recall details
- Recall number
- Z-0628-2018
- Status
- Terminated
- Initiated by the company
- Aug 25, 2017
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 11 devices
- Product code
- JWH
- FDA submissions
- K833921
- Distribution
- US Nationwide Distribution to IN, MO, NY, TX.
Product description
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Code information (models, lots, serial numbers)
Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BIOMET PATELLAR SYSTEM 150804Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K833921 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BIOMET PATELLAR SYSTEM 150802Biomet Orthopedics, LLC · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall0 reports
- AGC V2 TOTAL KNEE SYSTEM 155033Biomet Orthopedics, LLC · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 79095).
- Z-0627-2018 · TerminatedAGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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