Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect that prevents assembly, which aligns with the criteria for a moderate severity score involving low-risk issues or voluntary precautionary actions without reported harm.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM. The recall affects Item No. 814309180, Lot No. 459250, with an expiration date of 05/27/2027. The products were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated after it was detected during the rework process for an April 17, 2017, field action that the set screw and sleeve assembly, which are designed to have an interference fit, were no longer in the installed location. This defect could prevent the product assembly with the mating screw and targeting jig.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 638
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 (4)
- Item No. 814309180
- Lot No. 459250
- Exp. Date 05/27/2027
- UDI (01)00887868037962 (17)270527 (10)459250
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 65 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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