FDAFDA · Food and drugs·Recall number Z-0238-2019
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Published October 31, 2018 · Recall initiated: September 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
- Lot
- Lot Numbers: L734474
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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