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.
Recall
- Recall Number
- Z-2529-2018
- Event Number
- 80393
- Firm
- Nobel Biocare Usa Llc
- FEI Number
- 1000125598
- Product Code
- NHA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 16, 2018
- Posted
- July 23, 2018
- Terminated
- September 11, 2018
- Address
- 22715 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4609
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.
The product label has missing information, such as the lot number and expiration date, as well as other information.
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.
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.
74 units were distributed to the U.S.