Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 27 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, and the hazard involves a potential 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 13 mm x 300 mm (Item Number 814313300). The recall involves Lot Numbers 616680 and 616780. The product is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that the sterile packaging was already open when the product was opened in surgery. This presents a risk of contamination to the medical device.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers should stop using the affected lots and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 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: 616680 616780
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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