Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because sterile packaging was found open during 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, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 51 units of the Affixus Hip Fracture Nail Right 125 9 mm x 340 mm (Item Number 814309340). The recall was initiated after complaints indicated that the sterile packaging for these devices was already open when they were opened in surgery. The affected lot numbers are 244100, 584910, and 616470.
The recalled products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The devices are intended for the fixation of fractures.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions regarding the recall.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 51
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: 244100 584910 616470
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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