Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were 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 medical device where the sterile packaging was compromised, creating a risk of infection or other harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 51 units of the Affixus Hip Fracture Nail Right 125 11 mm x 420 mm (Item Number 814311420). The product is intended for the fixation of fractures. The recall was initiated after complaints indicated that when the product was opened in surgery, the sterile packaging was already open.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. The specific lot numbers involved are 289160, 369250, and 369260.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected products. Consumers who have had this device implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 51
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: 289160 369250 369260
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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FDA (Devices) · 2018-10-24
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