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 is classified as FDA Class II. The hazard involves a mechanical defect that could prevent proper assembly of a high-risk medical device, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM. The recall was initiated after 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 US, as well as in Portugal and the Netherlands. The specific lot numbers and expiration dates for the affected units are 480070 (06/12/2027), 858790 (06/12/2027), and 893450 (06/15/2027).
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Consumers should contact their healthcare provider if they have had this device implanted to discuss the recall and any necessary follow-up care.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
- 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 (3)
- Item No. 814511300
- 858790 (06/12/2027) UDI (01)00887868039133 (17)270612 (10)858790
- 893450 (06/15/2027) UDI (01)00887868039133 (17)270615 (10)893450
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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