Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper product assembly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical defect that prevents proper assembly, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM (Item No. 814609300). The affected lots are 595480, 788380, and 973000. The product was 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 the installed location. This defect could prevent the product assembly with the mating screw and targeting jig.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 9MM 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. 814609300
- 788380 (06/15/2027) UDI (01)00887868039676 (17)270615 (10)788380
- 973000 (07/10/2027) UDI (01)00887868039676 (17)270710 (10)973000
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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