Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
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 involves a medical device with a risk of harm (loss of sterility) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 14 units of the Affixus Hip Fracture Nail Left 125 9 mm x 320 mm (Item Number 814409320). The product is intended for the fixation of fractures. The recall is limited to Lot Number 558060.
The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. This defect compromises 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 patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 14
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:558060
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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