Z-0150-2015 Class II Terminated
FDA device recall Z-0150-2015 was initiated by Medartis, Inc. on October 1, 2014 and is designated Class II. Reason for recall: A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. The recall status is terminated (terminated August 6, 2015). Affected quantity: 44.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2014
- Initiation Date
- October 1, 2014
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44
Product Description
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
Reason for Recall
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Distribution Pattern
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Code Information
Part no. A-2791.05, lot no. 14125026