FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0150-2015
- Recalling firm
- Medartis, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-10-01
- Posted
- 2014-10-30
- Terminated
- 2015-08-06
- 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.
- Lot, serial or model codes
- Part no. A-2791.05, lot no. 14125026
- 510(k) numbers
- ["K141232"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3005215824
- Firm city
- Kennett Square
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28