Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 18 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in 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 is a breach of sterile packaging, which is a significant quality issue, but the source text does not report any specific illnesses, injuries, or hospitalizations resulting from the use of these specific units.
Plain-English summary
Zimmer Biomet, Inc. is recalling 18 units of the Affixus Hip Fracture Nail Right 125 11 mm x 460 mm (Item Number 814311460). The product is intended for the fixation of fractures. The recall is limited to Lot Number 436200.
The recall was initiated due to complaints indicating that the sterile packaging was already open when the product was opened in surgery. This defect compromises the sterility of the medical device.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers and facilities should stop using the affected lots and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 18
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: 436200
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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