Date Initiated by Firm | August 09, 2018 |
Create Date | September 27, 2018 |
Recall Status1 |
Terminated 3 on May 12, 2020 |
Recall Number | Z-3264-2018 |
Recall Event ID |
80921 |
510(K)Number | K080685 |
Product Classification |
Device, fixation, proximal femoral, implant - Product Code JDO
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Product | HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate
Item Number: 2110-140-004
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 3170094 3369699 3622113 3664778 3680647 |
Recalling Firm/ Manufacturer |
Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom
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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 | 6 units |
Distribution | US Nationwide in the states of AZ, MO, NJ and NM |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JDO
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