Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 78 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 compromised sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 78 units of the Affixus Hip Fracture Nail Left 125 9 mm x 300 mm (Item Number 814409300). The recall is due to complaints indicating that the sterile packaging was already open when the product was opened in surgery.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved are 201230, 201240, 500030, and 679050.
This recall is classified as Class II by the FDA. Healthcare providers should stop using the affected lots and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 78
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: 201230 201240 500030 679050
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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