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Recall Observatory FDA recall evidence

Device product

Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.

Z-1856-2020

August 09, 2019

Class II

Product summary

Firm
Nobel Biocare Usa Llc
Event
Event 85159
Status
Terminated
Classification
Class II
Quantity
238 pieces
Official record key
device-enforcement:Z-1856-2020

Official wording

Reason: Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

Code information: Catalog no. 38214, Lot no. 13076822, UDI: (01)07332747096538(10)13076822

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.