Home / Recalls / Zimmer Biomet, Inc. / Z-0627-2018

Z-0627-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
February 21, 2018
Initiation Date
August 25, 2017
Termination Date
August 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 devices

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.

Distribution Pattern

US Nationwide Distribution to IN, MO, NY, TX.

Code Information

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).

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  • Z-0696-2021 Class II — Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutt (November 20, 2020)
  • Z-0570-2021 Class II — Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacr (November 17, 2020)
  • Z-0362-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)
  • Z-0333-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutr (September 24, 2020)
  • Z-0335-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0328-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0327-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neut (September 24, 2020)
  • Z-0379-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 d (September 24, 2020)
  • Z-0341-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut (September 24, 2020)
  • Z-0385-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)