Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 39 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 is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 39 units of the Affixus Hip Fracture Nail Right 130 11 mm x 320 mm (Item Number 814511320). The recall involves Lot Numbers 616240 and 616250. The product is intended for the fixation of fractures.
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 medical device.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers and patients who have received this specific product should contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 39
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: 616240 616250
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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