AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Reported: February 21, 2018 Initiated: August 25, 2017 #Z-0627-2018
Product Description
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Reason for Recall
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 28 devices
- Distribution
- US Nationwide Distribution to IN, MO, NY, TX.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.. Recalled by Zimmer Biomet, Inc.. Units affected: 28 devices.
Why was this product recalled? ▼
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0627-2018.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11