Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
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. The hazard involves a packaging defect that compromises sterility, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Zimmer Biomet, Inc. is recalling 22 units of the Affixus Hip Fracture Nail Right 125 13 mm x 280 mm (Item Number 814313280). The product is intended for the fixation of fractures.
The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. The affected units are from Lot Number 369340.
The products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers should stop using the affected units and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 22
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: 369340
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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