Z-0238-2019 Class II Terminated
FDA device recall Z-0238-2019 was initiated by Synthes (USA) Products LLC on Sep 12, 2018 and is designated Class II. 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. The recall status is terminated (terminated Apr 10, 2020). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Sep 12, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0238-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026