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 the set screw and sleeve assembly from staying in place.
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 functional defect that could prevent proper assembly, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM. The affected product is identified by Item No. 814309340 and Lot No. 581620, with an expiration date of 05/26/2027.
The recall was initiated because it was detected during a rework process for a previous field action that the set screw and sleeve assembly, which are designed to have an interference fit, were no longer in the installed location. This defect could prevent the product assembly with the mating screw and targeting jig.
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 further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
- 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. 814309340
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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