Device product
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.
Z-0238-2019
Product summary
- Event
- Event 81152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-0238-2019
Official wording
Reason: 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.
Code information: Lot Numbers: L734474
Distribution pattern: US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Derived failure modes
-
Unknown
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.