Z-2835-2016 Class II Terminated
FDA device recall Z-2835-2016 was initiated by Ortho Solutions Inc on July 21, 2016 and is designated Class II. Reason for recall: Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. The recall status is terminated (terminated October 12, 2016). Affected quantity: 15.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- July 21, 2016
- Termination Date
- October 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
Product Description
FPS 35mm x 3.5 mm non-locking screw
Reason for Recall
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Distribution Pattern
US Distribution
Code Information
Part number - OS326835 Lot number: 10100/269A12-68051