Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 14 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, and the hazard involves compromised sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 14 units of the Affixus Hip Fracture Nail Left 130 11 mm x 360 mm (Item Number 814611360). The recall is being conducted because there were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot number involved is 289190.
Consumers and healthcare providers should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 14
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: 289190
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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