Recall Z-0150-2015 ยท HWC Screw, Fixation, Bone
Medartis, Inc.
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
| Date | Oct 30, 2014 (initiated Oct 1, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | The recall is being extended to end user level of distribution. The sales representatives, customers and a distributor were notified via phone or email on September 19th and notified of the recall via US mail on 10/1/14. US customers, distributors, and sales representatives were instructed to return the affected instrument kits to the importer Medartis, Inc. via transport agency. |
| Quantity | 44 |
| Distribution | US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141232 | APTUS ULNA SHORTENING 2.5 Medartis AG, Jun 23, 2014 |