Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential but unreported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the Affixus Hip Fracture Nail Left 125 9 mm x 260 mm (Item Number 814409260). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery.
The affected product is intended for the fixation of fractures. The specific lot number involved is 679000. The products were distributed worldwide, including nationwide in the United States across 38 states and territories, as well as to Chile and the Netherlands.
This is a Class II recall, which means the product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected units and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 16
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: 679000
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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Similar recalls
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
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