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U.S. Department of Health and Human Services

Class 2 Device Recall APTUS Ulna Shortening 2.5

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 Class 2 Device Recall APTUS Ulna Shortening 2.5see related information
Date Initiated by FirmOctober 01, 2014
Date PostedOctober 30, 2014
Recall Status1 Terminated 3 on August 06, 2015
Recall NumberZ-0150-2015
Recall Event ID 69433
510(K)NumberK141232 
Product Classification Screw, fixation, bone - Product Code HWC
ProductAPTUS 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
FEI Number 3005215824
Recalling Firm/
Manufacturer		 Medartis, Inc.
127 W Street Rd Ste 203
Kennett Square PA 19348-1698
For Additional Information ContactCustomer 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
ActionThe 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 Commerce44
DistributionUS Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HWC
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