Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
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 compromised sterile packaging, which is a significant quality defect, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 15 units of the Affixus Hip Fracture Nail Left 125 11 mm x 320 mm (Item Number 814411320). 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 recall includes units distributed nationwide in the United States and in the foreign countries of Chile and the Netherlands. The specific lot number for the recalled items is 679160.
Healthcare providers and facilities should stop using the affected product and contact Zimmer Biomet for instructions on return or replacement. Patients who have had this specific implant placed should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 15
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: 679160
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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