Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 32 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 a breach in sterile packaging presents a significant risk of infection or harm, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 32 units of the Affixus Hip Fracture Nail Left 125 13 mm x 360 mm (Item Number 814413360). The product is intended for the fixation of fractures. The recall involves Lot Numbers 369400 and 369410.
The recall was initiated due to complaints indicating that when the product was opened in surgery, the sterile packaging was already open. This condition raises concerns about the sterility of the medical device at the time of use.
The affected products were distributed worldwide, including nationwide in the United States and in Chile and the Netherlands. Healthcare providers and facilities that have received these specific lot numbers should stop using the product and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 32
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: 369400 369410
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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