The Recall Desk

Hazard

Sterile Packaging Failure recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2018-10-24

Of the 5 sterile packaging failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile packaging failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • HighFDA (Devices)·Z-0160-2019·2018-10-24

    Recall of Affixus Hip Fracture Nail Over Sterility Issue

    Zimmer Biomet is recalling the Affixus Hip Fracture Nail because sterile packaging was found already open during surgery. The affected lot was distributed in the US and internationally.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 33 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed nationwide and in Chile and the Netherlands.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2018·2018-05-02

    Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1467-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to potential sterile packaging seal failures.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
    Category
    Medical Device
    Distribution
    Distributed nationwide