Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
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 risk, but the source text does not report any specific illnesses, injuries, or hospitalizations, placing it in the Moderate category rather than Severe.
Plain-English summary
Zimmer Biomet, Inc. is recalling 20 units of the Affixus Hip Fracture Nail Right 125 11 mm x 440 mm (Item Number 814311440). 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 369280. The products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands.
Healthcare providers and facilities that have received this product should stop using it and contact Zimmer Biomet for instructions on how to return or dispose of the units.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 20
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: 369280
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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