Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
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. The hazard involves compromised sterile packaging, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Zimmer Biomet, Inc. is recalling 24 units of the Affixus Hip Fracture Nail Right 125 9 mm x 360 mm (Item Number 814309360). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery.
The affected product is intended for the fixation of fractures. The specific lot number involved is 219760. The products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands.
Healthcare providers should stop using the affected product and contact Zimmer Biomet for instructions on return or replacement. Patients who have had this product implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 24
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)
- Lot Numbers: 219760
Distribution
Part of a larger recall action
This product is one of 48 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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