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U.S. Department of Health and Human Services

Class 2 Device Recall The HipLOC Compression Hip Screw

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  Class 2 Device Recall The HipLOC Compression Hip Screw see related information
Date Initiated by Firm August 09, 2018
Create Date September 27, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-3261-2018
Recall Event ID 80921
510(K)Number K080685  
Product Classification Device, fixation, proximal femoral, implant - Product Code JDO
Product HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate
Item Number: 2110-130-004

Product Usage:
The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
Code Information Lot Number: 3222008
Recalling Firm/
Manufacturer		 Biomet UK Ltd.
Waterton Industrial Estate
Bridgend United Kingdom
For Additional Information Contact 411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		 HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
FDA Determined
Cause 2		 Process design
Action Zimmer Biomet issued US recall notices issued on August 9, 2018 via email and FedEx to Distributors and Hospitals advising of the problem and instruction to remove and return.Your Zimmer Biomet sales representative will remove the affected product from your facility. Complete Attachment 1  Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.comnistructions.mailto:CorporateQQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 1 unit
Distribution US Nationwide in the states of AZ, MO, NJ and NM
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 = JDO and Original Applicant = BIOMET MANUFACTURING, INC.
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