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NobelReplace recallZ-1303-2020 · Nobel Biocare Usa Llc · initiated Mar 14, 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

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

FDA root cause category: Packaging process control

What the company is doing

On 3/27/2018 the firm issued a recall notice by email to affected consignees. The recall notification informed the following actions to be taken by the consignees: 1. Identify affected devices as detailed in the Customer Reply Form. 2. Do not use affected devices. 3. Send back the Customer Reply Form and the affected devices. The firm will replace affected devices free of charge. This letter needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We kindly ask you to follow instructions provided in this Recall Letter and return the attached Customer Reply Form to the firm via email or fax at 714- 282-5073.

Recall details

Recall number
Z-1303-2020
Status
Terminated
Initiated by the company
Mar 14, 2019
Posted by the FDA
Feb 19, 2020
Recalling firm
Nobel Biocare Usa Llc
Quantity
8 units
Product code
DZi
FDA submissions
K990846
Distribution
Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

Product description

Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

Code information (models, lots, serial numbers)

(01)07332747065756(10)73466  Catalog# 37045

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 84450).

Sources and updates

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