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
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, and the source text describes a functional defect that prevents assembly but does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM. The affected devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated because, during a rework process for a field action conducted on April 17, 2017, it was detected that the set screw and sleeve assembly were no longer in their installed locations. These components are designed to have an interference fit, and their displacement could prevent the product assembly from working correctly with the mating screw and targeting jig.
Healthcare providers and facilities should check their inventory for the specific item number 814513300 and lot numbers 581970 (expiration date 06/01/2027) and 942010 (expiration date 06/24/2027). Affected units should be removed from use and returned to the manufacturer or their authorized representative.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- 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. 814513300
- 942010 (06/24/2027) UDI (01)00887868039270 (17)270624 (10)942010
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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