Z-1800-2015 Class II Terminated
FDA device recall Z-1800-2015 was initiated by Synthes, Inc. on May 13, 2015 and is designated Class II. Reason for recall: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. The recall status is terminated (terminated August 18, 2016). Affected quantity: 54.
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2015
- Initiation Date
- May 13, 2015
- Termination Date
- August 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54
Product Description
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Reason for Recall
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Distribution Pattern
Nationwide Distribution
Code Information
Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046