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 involves a high-risk medical device where a defect could prevent proper assembly, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM. 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 the installed location.
The affected 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. The recalled devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
Healthcare providers and facilities should check their inventory for the specific item number 814511360 and lot number 862170. Patients who have received this device should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
- 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. 814511360
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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