APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, i
FDA device recall Z-0150-2015 · posted 2014-10-30 · Terminated
Recall details
- Recalling firm
- Medartis, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 44
- Distribution
- US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
- Date initiated
- 2014-10-01
- Date posted
- 2014-10-30
- Date terminated
- 2015-08-06
- Location
- Kennett Square, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APTUS ULNA SHORTENING 2.5 (K141232) | Medartis AG | 2014-06-23 |