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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a structural defect in a medical device, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail Left 130° 9 mm x 420 mm (Item Number: 814609420). 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 37 U.S. states and Puerto Rico, as well as to Chile, Ecuador, Japan, and the Netherlands. The agency has classified this as a Class II recall.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420
- 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)
- 762840
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.
See all 129 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mechanical failure
See all →- HighBYD Recalls 2023-2024 Ride Type A School Buses for Lift Defect
NHTSA · 2026-10-22
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Similar recalls
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue
FDA (Devices) · 2018-11-21
- SevereZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
FDA (Devices) · 2018-02-07