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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall 17 MultiUnit Abutment, Conical Connection NP, 2.5mm see related information
Date Initiated by Firm March 16, 2018
Date Posted July 23, 2018
Recall Status1 Terminated 3 on September 11, 2018
Recall Number Z-2529-2018
Recall Event ID 80393
510(K)Number K072570  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product Nobel 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 Contact Ms. 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
Action Nobel 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 Commerce 74 units were distributed to the U.S.
Distribution Worldwide 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 Cycle TPLC 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) Database 510(K)s with Product Code = NHA and Original Applicant = NOBEL BIOCARE AB
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