Device product
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
Z-0150-2015
Product summary
- Firm
- Medartis, Inc.
- Event
- Event 69433
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44
- Official record key
device-enforcement:Z-0150-2015
Official wording
Reason: A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Code information: Part no. A-2791.05, lot no. 14125026
Distribution pattern: US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Derived failure modes
-
Unknown
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.