Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in 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 high-risk medical device where the loss of sterile packaging creates a significant risk of infection or harm, 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 153 units of the Affixus Hip Fracture Nail 125 9 mm x 180 mm (Item Number 814309180). The product is intended for the fixation of fractures.
The recall was initiated due to complaints indicating that when the product was opened in surgery, the sterile packaging was already open. This issue compromises the sterility of the medical device.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved are 177820, 177830, 177890, 177910, 177920, 244120, and 287770. Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers and stop using the affected devices.
The recalled product
- Product
- Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 153
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: 177820 177830 177890 177910 177920 244120 287770
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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