Zimmer Biomet Recalls Affixus Hip Fracture Nail 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for medical devices with potential for serious adverse health consequences.
Plain-English summary
Zimmer Biomet, Inc. is recalling 5,947 units of the Affixus Hip Fracture Nail 130 11 mm x 180 mm (Item Number: 814511180). 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 recall covers specific lot numbers listed in the agency's official documentation.
Healthcare providers and patients should contact Zimmer Biomet for instructions on how to proceed with the recall. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 5,947
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 →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- 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 Issue
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
FDA (Devices) · 2018-02-07
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
FDA (Devices) · 2018-11-21
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction
FDA (Devices) · 2018-11-21