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U.S. Department of Health and Human Services

Class 2 Device Recall Distal Radius Fracture Repair System

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  Class 2 Device Recall Distal Radius Fracture Repair System see related information
Date Initiated by Firm June 23, 2014
Date Posted August 13, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall Number Z-2212-2014
Recall Event ID 68651
510(K)Number K052248  K041081  
Product Classification Plate, fixation, bone - Product Code HRS
Product Device Brand Name: Distal Radius Fracture Repair System
Device Classification Name: Plate, Fixation, Bone
Device Common Name: Drill Guide DNP 3.3mm
Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
Code Information Catalog Number: DNPDG, Lot Number: NB0311 and NB0611
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Craig Buchman
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On June 23, 2014 Biomet issued recall notification to their consignees via letter. Notification included affected product issue and instructions for return were provided. Distributors who had affected hospitals in their regions were notified and provided with a copy of the notice that was sent to the hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. A response form was provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.
Quantity in Commerce 37
Distribution The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,
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 = HRS and Original Applicant = HAND INNOVATIONS, INC.
510(K)s with Product Code = HRS and Original Applicant = HAND INNOVATIONS, LLC.
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