Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 30 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a risk of infection.
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 3/5 (High).
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 involves a high-risk medical device where the sterile barrier was compromised, creating a significant risk of infection, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 30 units of the Affixus Hip Fracture Nail Left 125 9 mm x 460 mm (Item Number 814409460). The recall was initiated after complaints indicated that the sterile packaging for these devices was already open when the product was opened in surgery.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved in this recall are 584760 and 584770.
Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact Zimmer Biomet for instructions on how to return or dispose of the product. Patients who have already had these devices implanted should contact their healthcare provider to discuss the potential risks associated with the compromised sterile packaging.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 30
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: 584760 584770
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.
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Similar recalls
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