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Universal Base CC RP 1.5 mm recallZ-1856-2020 · Nobel Biocare Usa Llc · initiated Aug 9, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nobel Biocare Usa Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-1856-2020
Status
Terminated
Initiated by the company
Aug 9, 2019
Recalling firm
Nobel Biocare Usa Llc
Quantity
238 pieces
Product code
DZE
FDA submissions
K925762
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 85159).

Sources and updates

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