Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 19 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. The hazard involves compromised sterile packaging, which is a significant quality control issue, but the source text does not report any specific injuries, illnesses, or hospitalizations resulting from the use of these devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19 units of the Affixus Hip Fracture Nail Right 125 9 mm x 380 mm (Item Number 814309380). The recall was initiated after complaints indicated that the sterile packaging for these 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 distributed nationwide in the United States and in the foreign countries of Chile and the Netherlands. The specific lot number for the recalled product is 436160.
This recall is classified as Class II by the FDA. Healthcare providers and facilities that have received these specific devices should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19
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: 436160
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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