Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 27 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 breach of sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 27 units of the Affixus Hip Fracture Nail Right 125 11 mm x 340 mm (Item Number 814311340). The product is intended for the fixation of fractures. The recall is being conducted because complaints indicated that the sterile packaging was already open when the product was opened in surgery.
The affected lot numbers are 244090 and 288670. The products were distributed worldwide, including nationwide in the United States and to Chile and the Netherlands. The source text does not specify the number of patients affected or report any illnesses or injuries resulting from the use of these devices.
Healthcare providers should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of the product. Patients who have had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 27
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: 244090 288670
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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