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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 Systemsee related information
Date Initiated by FirmJune 23, 2014
Date PostedAugust 13, 2014
Recall Status1 Terminated 3 on July 14, 2015
Recall NumberZ-2212-2014
Recall Event ID 68651
510(K)NumberK041081 K052248 
Product Classification Plate, fixation, bone - Product Code HRS
ProductDevice 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 ContactCraig 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
ActionOn 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 Commerce37
DistributionThe 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 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 = HRS
510(K)s with Product Code = HRS
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