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.
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, which typically corresponds to a moderate severity score. The issue is a packaging design verification gap rather than a direct safety hazard like contamination or structural failure, and no injuries or illnesses are reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 7,888 units of the Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length (Item Number 47-2255-008-00). The recall affects all lot numbers with an expiry date before April 2022. These medical devices are used during the initial reaming of the intramedullary canal and assist in guiding the nail during implantation.
The recall was initiated 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. Healthcare facilities and distributors should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 7,888
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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