Recall of Affixus Hip Fracture Nail Over Sterility Issue
Zimmer Biomet is recalling the Affixus Hip Fracture Nail because sterile packaging was found already open during surgery. The affected lot was distributed in the US and internationally.
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: This is an FDA Class II recall for a medical device with compromised sterility, presenting a risk of infection where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340, Lot Number 369640. This medical device is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that when the product was opened during surgery, the sterile packaging was already open. This compromises the sterility of the implant and poses a risk of infection.
A total of 24 units are affected by this recall. These units were distributed nationwide in the United States (including states such as California, Texas, New York, and Florida) and internationally to Chile and the Netherlands.
Healthcare providers and facilities are advised to inspect their inventory for the affected lot number and follow the manufacturer's instructions regarding the return or disposal of the recalled units.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 24
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: 369640
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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