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, 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 and involves a risk-of-harm product (medical device) where the defect could prevent proper assembly, but 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, RH 125 DEG 13MM X 320MM (Item No. 814313320). The affected units were 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, 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 should identify any affected units using the provided lot and expiration date information and stop using them. Zimmer Biomet is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
- 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. 814313320
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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