Home / Recalls / Zimmer Biomet, Inc. / Z-0323-2021

Z-0323-2021 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
November 11, 2020
Initiation Date
September 24, 2020
Termination Date
May 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
412 units total

Product Description

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component

Reason for Recall

Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Distribution Pattern

US Nationwide

Code Information

All lots

Other recalls by Zimmer Biomet, Inc.

  • 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-0388-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d (September 24, 2020)
  • Z-0351-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neu (September 24, 2020)
  • Z-0325-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 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-0335-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0369-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 d (September 24, 2020)
  • Z-0380-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d (September 24, 2020)
  • Z-0386-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)