Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 17 MultiUnit Abutment, Conical Connection NP, 2.5mm

  • 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 17 MultiUnit Abutment, Conical Connection NP, 2.5mmsee related information
Date Initiated by FirmMarch 16, 2018
Date PostedJuly 23, 2018
Recall Status1 Terminated 3 on September 11, 2018
Recall NumberZ-2529-2018
Recall Event ID 80393
510(K)NumberK072570 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductNobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.
Code Information Lot #1270802
Recalling Firm/
Manufacturer		 Nobel Biocare Usa Llc
22715 Savi Ranch Pkwy
Yorba Linda CA 92887-4609
For Additional Information ContactMs. Sandra Cedillo
714-282-4800
Manufacturer Reason
for Recall		The product label has missing information, such as the lot number and expiration date, as well as other information.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionNobel Biocare sent an Urgent Quality Message letter dated March 13, 2018 via email to the U.S. consignees. The letter identified the affected product, problem and actions to be taken. For question contact customer service department at 800-322-5001.
Quantity in Commerce74 units were distributed to the U.S.
DistributionWorldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hong Kong, Italy, Japan, Lebanon, Mexico, Spain, and Switzerland.
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 = NHA
-
-