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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a packaging design verification issue rather than a direct safety hazard or reported injury, aligning with the 'Moderate' criteria for voluntary precautionary recalls or minor issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires (Item Number 00-2255-025-00). These smooth, 2.4 mm diameter, 70 cm length guide wires are single-use medical devices used during the initial reaming of the intramedullary canal and to guide the nail during implantation.
The recall is being conducted because 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, resulting in the removal of products packaged in the previous configuration.
The affected products were distributed nationwide within the U.S.A. and Puerto Rico, as well as internationally in Australia, Brazil, Canada, China, Germany, India, Japan, the Netherlands, and Singapore. The recall includes all lot numbers with an expiry date before April 2022. Healthcare facilities should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- 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 guidin
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 6,290
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot Numbers Expiry Date Before April 2022
Distribution
Part of a larger recall action
This product is one of 5 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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