Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 12 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 the source text does not report any specific injuries, illnesses, or deaths, placing it in the moderate range for a precautionary quality recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 12 units of the Affixus Hip Fracture Nail Right 125 11 mm x 360 mm (Item Number 814311360). The recall was initiated after complaints indicated that the sterile packaging for the devices was already open when the product was opened in surgery.
The affected devices, identified by Lot Number 244170, were distributed nationwide in the United States and to foreign countries including Chile and the Netherlands. The products are intended for the fixation of fractures.
Consumers and healthcare providers should stop using the affected devices and contact Zimmer Biomet for further instructions on handling or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
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: 244170
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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