Nobel Biocare Usa Llc 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

Urgent Medical Device Recall Letters were sent to U.S. customers via the U.S Postal Service and OUS customers via email beginning on August 9, 2019. This communication notified customers that the firm had identified a packaging issue affecting six product codes and a total of 7 lots of medical devices (titanium abutments) where the packages of abutment lots may contain an incorrect screw. Customers were informed that while the screw will tighten, it cannot be guaranteed that the screw will not loosen. If the screw loosens, customers are instructed to retighten the abutment with the correct screw. Customers were requested to: i1) identify all devices of the affected lots which they have in stock, 2) not to use the affected devices, 3) complete the Customer Acknowledgement Form and, 4) return it to Nobel Biocare via email at us.complaints@nobelbiocare.com or by fax to 714-282-5073, within 5 days of receipt of the Urgent Medical Device Recall Letter. Customers were instructed to return all devices from affected lots to Nobel Biocare, Attn: Returns PFA1914, 22715 Savi Ranch Parkway, Yorba Linda, CA 92887. The Urgent Medical Device Recall Letter notes that the manufacturer has reviewed the packaging process, has implemented corrective actions and will initiate preventive actions. The letter requests that customers pass the letter on to all those who need to be aware within their organizations or to any organization where the potentially affected devices have been transferred. Customers were instructed to contact their customer support representative at 1-800-322-5001, ext. 1527, if they require further information or support.