Z-0238-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- September 12, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Code Information
Lot Numbers: L734474