Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
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 medical device where the sterile barrier was compromised, creating a risk of infection or harm, but no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19 units of the Affixus Hip Fracture Nail Left 130 9 mm x 360 mm (Item Number 814609360, Lot Number 616460). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery.
The affected products were distributed nationwide in the United States and to foreign countries including 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 Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19
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: 616460
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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