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 may have displaced internal components, 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. The hazard involves a mechanical defect that prevents proper assembly of a medical device, which poses a risk of harm during surgical use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM. The affected product is identified by Item No. 814609280 and Lot No. 936100, with an expiration date of 06/15/2027. The recall covers units 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 field action on April 17, 2017, that the set screw and sleeve assembly were no longer in their installed locations. These components are designed to have an interference fit. Their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.
This 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. Healthcare providers and facilities should stop using the affected units and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
- 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 (1)
- Item No. 814609280
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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