Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 85 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
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 hazard involves a packaging defect (open sterile packaging) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 85 units of the Affixus Hip Fracture Nail 130 11 mm x 180 mm (Item Number 814511180). The recall was initiated after complaints indicated that the sterile packaging for the devices was already open when the product was opened in surgery.
The affected devices are intended for the fixation of fractures. The recall includes units with lot numbers 136520, 244300, 244320, and 436430. These products were distributed nationwide in the United States and to foreign countries including Chile and the Netherlands.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 85
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: 136520 244300 244320 436430
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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