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 is classified as FDA Class II, and the defect poses a risk of harm by preventing proper assembly of a medical device, although no injuries or illnesses have been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM. The recall was initiated after a defect was detected during a rework process for a previous field action. The issue involves the set screw and sleeve assembly, which are designed to have an interference fit, no longer being in the 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. The specific lot number is 438020, with an expiration date of May 18, 2027. The item number is 814509440.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions on how to return or replace the product. Patients who have already received the device should consult their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
- 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. 814509440
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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