Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.
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, and the defect presents a risk of harm to patients by preventing proper device assembly, but no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM. The affected product is identified by Item No. 814411440, Lot No. 459240, and an expiration date of 05/21/2027. The recall covers units distributed nationwide in the United States, as well as in Portugal and the Netherlands.
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 location. These components are designed to have an interference fit, and 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 units and contact Zimmer Biomet for instructions on how to return or dispose of the product. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
- 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. 814411440
- Lot No. 459240
- Exp. Date 05/21/2027
- UDI (01)00887868038525 (17)270521 (10)459240
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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