Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 68 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
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 illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 68 units of the Affixus Hip Fracture Nail Left 125 11 mm x 360 mm (Item Number 814411360). The recall was initiated after complaints indicated that the sterile packaging for these medical devices was already open when the product was opened in surgery. The affected lot numbers are 244290, 343530, and 343550.
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. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Hospitals and healthcare facilities should stop using the affected lots and contact Zimmer Biomet for instructions on how to return or dispose of the products. Patients who have had these specific devices implanted should contact their healthcare provider to discuss the recall and any potential follow-up care.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 68
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: 244290 343530 343550
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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