Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 25 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard is a potential breach of sterility, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling 25 units of the Affixus Hip Fracture Nail Right 125 13 mm x 440 mm (Item Number 814313440). The recall was initiated after complaints indicated that the sterile packaging for these devices was already open when the product was opened in surgery.
The affected products are intended for the fixation of fractures. The specific lot numbers involved in this recall are 678960 and 678970. The devices were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands.
Consumers and healthcare providers should check their inventory for these specific item numbers and lot numbers. If the sterile packaging is compromised, the devices should not be used. Zimmer Biomet is the recalling firm responsible for this action.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 25
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: 678960 678970
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.
See all 48 products in this recall →Related recalls
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