Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 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 involves a high-risk medical device where improper assembly could lead to adverse health consequences, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM (Item No. 814311460). The affected units are identified by Lot No. 788650 with an expiration date of 06/05/2027. The product was 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 were no longer in the installed location. These components are designed to have an interference fit. This defect could prevent the product from being properly assembled with the mating screw and targeting jig.
This is a Class II recall, meaning there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. 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 recalled product
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 11MM 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. 814311460
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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