Date Initiated by Firm |
October 01, 2014 |
Date Posted |
October 30, 2014 |
Recall Status1 |
Terminated 3 on August 06, 2015 |
Recall Number |
Z-0150-2015 |
Recall Event ID |
69433 |
510(K)Number |
K141232
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
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.
|
Code Information |
Part no. A-2791.05, lot no. 14125026 |
Recalling Firm/ Manufacturer |
Medartis, Inc. 127 W Street Rd Ste 203 Kennett Square PA 19348-1698
|
For Additional Information Contact |
Customer Support 610-961-6101 Ext. 202
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
44 |
Distribution |
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = MEDARTIS AG
|