Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
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 functional defect that could compromise the stability of a hip fracture fixation. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Right 130° 15 mm x 440 mm (Item Number: 814515440). The recall was initiated because the set screw is not able to advance or reverse from the original position in the nail.
The affected products were distributed to 38 US states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific states affected include AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,947
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)
- 154880
Distribution
Part of a larger recall action
This product is one of 129 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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