Affixus Hip Fracture Nails Recalled Due to Compromised Sterile Packaging
The FDA is recalling 72 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, creating a potential contamination risk.
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 involves a low-risk contamination issue (compromised sterile packaging) with no reported illnesses or injuries, which aligns with the rubric's definition of moderate severity for low-risk contamination and voluntary precautionary recalls.
Plain-English summary
The FDA is recalling 72 Affixus Hip Fracture Nails (Item Number 814309300) manufactured by Zimmer Biomet, Inc., because complaints indicated that the sterile packaging was already open when the product was opened during surgery. This compromise of sterility raises concerns about potential contamination if the devices are used in clinical settings.
These nails were distributed worldwide, including throughout the United States across multiple states and also exported to Chile and the Netherlands. Consumers are advised to discontinue use of these nails immediately and follow the manufacturer's instructions regarding proper handling and disposal. The recall is classified as FDA Class II and does not involve reported illnesses or injuries.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 72
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: 219750 244110 450750
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.
See all 48 products in this recall →Related recalls
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