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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall involving a structural defect in a medical device, which aligns with the rubric criteria for a Severe (4) rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 125° 13 mm x 380 mm (Item Number: 814413380). The recall is due to a defect where the set screw is unable to advance or reverse from the original position in the nail.
The affected products were distributed to 38 U.S. states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The specific distribution states 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 recall. The agency has classified this as a Class II recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380
- 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)
- 417480 646660
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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