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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 gap rather than a direct safety hazard or reported injury, aligning with the 'voluntary precautionary recalls' criterion for a Moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires (Item Number 00-2255-026-00). These medical devices are used during the initial reaming of the intramedullary canal and assist in guiding the nail during implantation. The specific units involved are 2.4 mm in diameter and 70 cm in length, with bullet tips, and are intended for single use only.
The recall was initiated because the design verification for the previous packaging configuration (G928) did not cover the 70cm wires. A new design verification has been completed to move the 70cm guide wires to a new packaging configuration. Consequently, products packaged in the previous configuration are being removed from distribution.
The affected units are 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 March 2022. Healthcare providers and facilities should stop using these specific guide wires and contact Zimmer Biomet for further instructions.
The recalled product
- 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…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,517
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 March 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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