Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
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 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 packaging defect that poses a theoretical risk of contamination, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the Affixus Hip Fracture Nail Left 130 11 mm x 400 mm (Item Number 814611400). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. The product is intended for the fixation of fractures.
The affected units, identified by Lot Number 500220, were distributed nationwide in the United States and to foreign countries including Chile and the Netherlands. The agency has classified this as a Class II recall.
Healthcare providers and patients should check their inventory and records for this specific item number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 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: 500220
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
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