The Recall Desk

FDA (Devices) recall action 78219

Zimmer Biomet, Inc. recalled 5 products on 2018-02-14

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-02-14
Critical
0
Units
27,442

Why these products were recalled

The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification Gap

    Zimmer Biomet is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm lengths.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 10,116 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification

    Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wire Ball Tip Due to Packaging Design Verification

    Zimmer Biomet is recalling 7,888 Humeral Guide Wire Ball Tip units because the previous packaging configuration lacks design verification for 70cm wires.

    Product
    Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide…
    Category
    Distribution
    1 state