Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.
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 2/5 (Moderate).
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. The hazard is a manufacturing defect that prevents proper assembly, which is a theoretical risk of harm rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM. The affected units were distributed nationwide in the United States, as well as in Portugal and the Netherlands. The specific item number is 814513460, with Lot No. 582360 and an expiration date of 05/26/2027.
The recall was initiated after it was detected during a rework process for a previous field action that the set screw and sleeve assembly were no longer in their installed locations. These components are designed to have an interference fit. Their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or replace the units. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
- 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 (1)
- Item No. 814513460
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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