Z-2529-2018 Class II Terminated
FDA device recall Z-2529-2018 was initiated by Nobel Biocare Usa Llc on Mar 16, 2018 and is designated Class II. Reason for recall: The product label has missing information, such as the lot number and expiration date, as well as other information. The recall status is terminated (terminated Sep 11, 2018). Affected quantity: 74 units were distributed to the U.S.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- Mar 16, 2018
- Termination Date
- Sep 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units were distributed to the U.S.
Product Description
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.
Reason for Recall
The product label has missing information, such as the lot number and expiration date, as well as other information.
Distribution Pattern
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.
Code Information
Lot #1270802
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2529-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026