Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework error may have displaced internal components, 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 presents a risk of harm to patients by preventing proper assembly of the medical device, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM. The affected devices are identified by Item No. 814411360, Lot No. 935900, and an expiration date of 06/15/2027. 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. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected devices were distributed nationwide in the United States, as well as in Portugal and the Netherlands. Healthcare facilities and distributors 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 125 DEG 11MM X 360MM
- 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 (4)
- Item No. 814411360
- Lot No. 935900
- Exp. Date 06/15/2027
- UDI (01)00887868038488 (17)270615 (10)935900
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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