Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 10 units of 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 hazard involves a potential breach of sterile packaging without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 10 units of Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400. 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 584890, were distributed worldwide. In the United States, the products 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 further instructions. Patients who have had these implants should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 10
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: 584890
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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