Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
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 potential sterility breach, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 153 units of the Affixus Hip Fracture Nail 125 11mm x 180mm (Item Number 814311180). The product is intended for the fixation of fractures. The recall is being conducted because there were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The affected lot numbers are 129900, 129910, 178050, 178060, 178070, 287720, and 287740. The products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. This recall is classified as Class II by the FDA.
Healthcare providers and facilities that have received these products should stop using them and contact Zimmer Biomet for instructions on how to return the devices. Patients who have already had the product implanted should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 153
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: 129900 129910 178050 178060 178070 287720 287740
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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