Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterile packaging, which is a significant quality issue, but the source text does not report any illnesses, injuries, or hospitalizations, placing it in the Moderate category per the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 20 units of the Affixus Hip Fracture Nail Right 130 11 mm x 400 mm (Item Number 814511400, Lot Number 343630). The product is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that the sterile packaging was already open when the product was opened in surgery. This condition raises concerns about the sterility of the implant.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. 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 Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 20
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)
- Lot Numbers: 343630
Distribution
Part of a larger recall action
This product is one of 48 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.
See all 48 products in this recall →Related recalls
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Similar recalls
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
FDA (Devices) · 2018-02-07
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
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