Zimmer Biomet Recalls Affixus Hip Fracture Nail 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 hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM. The recall was initiated after a defect was detected during a rework process for a field action conducted on April 17, 2017.
The issue involves the set screw and sleeve assembly, which are designed to have an interference fit. The defect caused these components to be no longer in the installed location. This condition could prevent the product from being properly assembled with the mating screw and targeting jig.
The affected devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands. The specific item number is 814511340, and the lot number is 581910 with an expiration date of May 25, 2027. Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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. 814511340
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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