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U.S. Department of Health and Human Services

Class 2 Device Recall ImplantDirect simply RePlant Implant

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 Class 2 Device Recall ImplantDirect simply RePlant Implantsee related information
Date Initiated by FirmAugust 07, 2018
Create DateOctober 01, 2019
Recall Status1 Terminated 3
Recall NumberZ-0010-2020
Recall Event ID 83086
510(K)NumberK061319 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Code Information Lot 108191, UDI (01)10841307108313(17)230118(10)108191
FEI Number 3001617766
Recalling Firm/
Manufacturer		 Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information ContactElizabeth Dunn
888-649-6425 Ext. 5467
Manufacturer Reason
for Recall		The incorrect device was packaged in the vial.
FDA Determined
Cause 2		Employee error
ActionThe recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned.
Quantity in Commerce158 devices
DistributionDistribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
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 = DZE
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