Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, 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 the defect presents a risk of harm (failure to install) for a high-risk medical device, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling Affixus Hip Fracture Nails (RH 130 DEG 9MM X 360MM) due to a manufacturing defect detected during a rework process. 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 assembly from working correctly with the mating screw and targeting jig.
The affected product was distributed nationwide in the United States, as well as in Portugal and the Netherlands. Specific lot numbers and expiration dates are identified in the recall documentation, including Item No. 814509360 with lots 555460, 892960, and 892990.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or replace the product. Consumers who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
- Manufacturer
- Zimmer Biomet, Inc.
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 (3)
- Item No. 814509360
- 892960 (06/14/2027) UDI (01)00887868038907 (17)270614 (10)892960
- 892990 (06/15/2027) UDI (01)00887868038907 (17)270615 (10)892990
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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