• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RePlant Angled Abutment Part Number 60505260

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RePlant Angled Abutment Part Number 60505260see related information
Date Initiated by FirmJuly 05, 2016
Date PostedAugust 02, 2016
Recall Status1 Terminated 3 on February 16, 2017
Recall NumberZ-2320-2016
Recall Event ID 74624
510(K)NumberK061319 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductRePlant Angled Abutment Part Number 6050-52-60
Code Information Lot #50174, 39799, 49364
Recalling Firm/
Manufacturer
Implant Direct Sybron Manufacturing, LLC
3050 E Hillcrest Dr
Westlake Village CA 91362-3171
For Additional Information Contact
818-444-3300 Ext. 3323
Manufacturer Reason
for Recall
Issue with design specification; oversized condition.
FDA Determined
Cause 2
Process control
ActionImplant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of the notification in order to provide the customers with the correct tool. If customers have any of the affected product listed the firm will send a replacement part. If any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in Commerce205
DistributionU.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
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
-
-