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U.S. Department of Health and Human Services

Class 2 Device Recall Construx Alum Ankle Clamp

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  Class 2 Device Recall Construx Alum Ankle Clamp see related information
Date Initiated by Firm May 01, 2015
Date Posted June 09, 2015
Recall Status1 Terminated 3 on December 08, 2015
Recall Number Z-1741-2015
Recall Event ID 71255
510(K)Number K111376  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Unilateral external fixation ankle clamp

Product Usage:
Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Code Information Part 14-450510 Lots:268000, 466170, and 813950
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.
FDA Determined
Cause 2		 Process control
Action Biomet sent an URGENT MEDICAL DEVICE RECALL NOTICE letter dated May 1, 2015 to the affected distributors and implanting surgeons. The recall letter included a description of the reason for the recall, affected product, consignee responsibilities, and distributor instructions for responding to the formal recall notification. Consignees were instructed to return the affected product and continued monitoring of patients. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 19
Distribution US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
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 = KTT and Original Applicant = EBI, LLC
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