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 involves a medical device with a defect that could prevent proper assembly, posing a risk of harm to patients, 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 130 DEG 13MM X 460MM. 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.
This defect 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.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or replace them. Patients who have already received the device should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 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. 814613460
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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