Home / Recalls / Zimmer Biomet, Inc. / Z-1465-2018

Z-1465-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
March 26, 2018
Termination Date
November 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19483 total products

Product Description

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Reason for Recall

Potential failure of sterile packaging seal.

Distribution Pattern

US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Code Information

Lot Numbers: 63733049 63738623 63748399 63753770 63758430 63849380 77006555 77006556 77006557

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  • Z-0570-2021 Class II — Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacr (November 17, 2020)
  • Z-0396-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap (September 24, 2020)
  • Z-0331-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0356-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu (September 24, 2020)
  • Z-0337-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neut (September 24, 2020)
  • Z-0343-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neut (September 24, 2020)
  • Z-0344-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neu (September 24, 2020)
  • Z-0384-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 d (September 24, 2020)
  • Z-0370-2021 Class II — ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 d (September 24, 2020)