Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a contamination risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the sterile barrier was compromised, creating a potential for infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 14 units of the Affixus Hip Fracture Nail Right 125 9 mm x 440 mm (Item Number 814309440). The recall is due to complaints indicating that the sterile packaging was already open when the product was opened in surgery.
The affected products, identified by Lot Number 289130, were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The products are intended for the fixation of fractures.
Consumers and healthcare providers should stop using the affected products and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 14
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: 289130
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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