Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 29 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were 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 the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 29 units of the Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440. The recall was initiated after complaints indicated that the sterile packaging for these devices was already open when the product was opened in surgery. The affected lot numbers are 584790 and 584810.
The recalled devices 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 devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 29
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: 584790 584810
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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