Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 20 units of the Affixus Hip Fracture Nail Right 125 11 mm x 380 mm (Item Number 814311380). The recall was initiated after complaints indicated that the sterile packaging was already open when the product was opened in surgery. The product is intended for the fixation of fractures.
The affected units, identified by Lot Number 244180, were distributed nationwide in the United States and to foreign countries including Chile and the Netherlands. The recall is classified as Class II by the FDA.
Healthcare providers and facilities should stop using the affected units and contact Zimmer Biomet for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 20
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: 244180
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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