Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product 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 high-risk medical device, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 638 units of the Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM (Item No. 814509300). The affected units were distributed nationwide in the United States, as well as in Portugal and the Netherlands.
The recall was initiated because, during the rework process for a field action conducted on April 17, 2017, it was detected 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.
Healthcare providers and facilities that have received these specific units should stop using them and contact Zimmer Biomet for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 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 (1)
- Item No. 814509300
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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