Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper installation.
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 involves a medical device defect that could prevent proper assembly and installation, posing a risk of harm, but no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM. The affected product is identified by Item No. 814311180, Lot No. 459190, and an expiration date of 05/17/2027. The recall was initiated after it was detected during a rework process for a field action that the set screw and sleeve assembly, which are designed to have an interference fit, were no longer in their installed location.
This defect could prevent the product assembly from working correctly with the mating screw and targeting jig. The FDA has classified this as a Class II recall. The affected units 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 the product. Patients who have already received the implant should consult their healthcare provider if they have concerns about the device's performance.
The recalled product
- Product
- Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
- 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. 814311180
- Lot No. 459190
- Exp. Date 05/17/2027
- (01)00887868038082 (17)270517 (10)459190
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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