Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.
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 involves a structural assembly issue in a high-risk medical device (orthopedic implant) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM (Item No. 814609320). The affected lots are 535150 (expiration date 05/24/2027) and 942050 (expiration date 06/15/2027). The devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
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 their installed location. This defect could prevent the product assembly with the mating screw and targeting jig.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible health consequences. Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
- 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. 814609320
- 942050 (06/15/2027) UDI (01)00887868039683 (17)270615 (10)942050
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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