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 the set screw and sleeve assembly from staying in place.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 hazard involves a mechanical defect in a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM. 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 from working correctly 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. The specific item number is 814409380, and the affected lot numbers are 398590 (expiration date 05/19/2027) and 702190 (expiration date 06/04/2027).
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 had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
- 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 (2)
- Item No. 814409380
- 702190 (06/04/2027) UDI (01)00887868038389 (17)270604 (10)702190
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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