Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 38 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
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 with a breach of sterile packaging, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 38 units of the Affixus Hip Fracture Nail Right 125 9 mm x 320 mm (Item Number 814309320). The recall is being conducted because complaints indicated that the sterile packaging was already open when the product was opened in surgery. The affected lot numbers are 450770 and 450790.
The recalled products were distributed worldwide, including nationwide in the United States and in the foreign countries of 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 instructions on how to return or dispose of them.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 38
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: 450770 450790
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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