Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes complaints regarding packaging integrity without reporting specific injuries or illnesses, fitting the criteria for a moderate severity recall involving potential contamination or misuse risks.
Plain-English summary
Zimmer Biomet, Inc. is recalling 20 units of the Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460. 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 products, identified by Lot Number 369120, were distributed worldwide. In the United States, they were distributed nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were also distributed to Chile and the Netherlands.
Healthcare providers should stop using the affected products and contact Zimmer Biomet for instructions on return or replacement. Patients who have had this specific product implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 20
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: 369120
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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