Date Initiated by Firm |
November 20, 2018 |
Create Date |
January 10, 2019 |
Recall Status1 |
Terminated 3 on April 14, 2020 |
Recall Number |
Z-0708-2019 |
Recall Event ID |
81704 |
510(K)Number |
K112345
|
Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component, metal composite - Product Code LXT
|
Product |
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile
ITEM 131827120
Product Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
|
Code Information |
LOT 029980 UDI (01)00880304535589(17)280501(10)029980 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact |
411 Technical Services 574-371-3071
|
Manufacturer Reason for Recall |
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. |
Quantity in Commerce |
50 pieces |
Distribution |
Country of Japan |
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 = LXT and Original Applicant = MEDOS INTERNATIONAL SARL
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