Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 33 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed nationwide and in Chile and the Netherlands.
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 source text describes a packaging defect without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 33 units of the Affixus Hip Fracture Nail Left 125 11 mm x 260 mm (Item Number 814411260). 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 244270 and 679300.
The recalled products were distributed worldwide, including to facilities in the United States and foreign countries such as Chile and the Netherlands. The devices are intended for the fixation of fractures.
Healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on how to return them. Patients who have had these specific devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 33
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: 244270 679300
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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