Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 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 is classified as FDA Class II. The hazard involves a mechanical failure of a medical implant (set screw inability to advance/reverse), which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products 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 125° 11 mm x 420 mm (Item Number: 814311420). 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 involved 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 facilities should contact Zimmer Biomet for instructions on how to handle the affected devices. Patients who have had this specific device implanted should consult their healthcare provider regarding the recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420
- 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)
- 060900 331520 417460 645670 688350 017270
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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