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 could prevent proper assembly of a medical implant, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM. The recall affects specific lots identified by Item No. 814609440 and Lot Nos. 507340 and 858900. The products 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 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. Their displacement could prevent the product from being properly assembled with the mating screw and targeting jig.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for instructions on how to return or dispose of the units. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
- 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. 814609440
- 858900 (06/14/2027) UDI (01)00887868039744 (17)270614 (10)858900
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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