Z-1324-2020Class II

Abutment Screw Retrieval Kit -

Name: Z-1324-2020 Abutment Screw Retrieval Kit -
Creator: Nobel Biocare Usa Llc
Published: 2019-03-14
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2019-03-14 / Terminated / root cause: packaging

FDA source

Nobel Biocare Usa Llc began a recall of Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown... on 2019-03-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1324-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-14
Posted: 2020-02-19
Terminated: 2024-02-15
Recalling firm: Nobel Biocare USA LLC
Product: Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 7 units
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 codes and lots: (01)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1324-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1302-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1303-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1304-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1305-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1306-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1307-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1308-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1309-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1310-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1311-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1312-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1313-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1314-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1315-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1316-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1317-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1318-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1319-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1320-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1321-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1322-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1323-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1324-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1325-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code DZE

K955697Class IIAbutment Retrieval KitNobelpharma USA, Inc. / cleared 1996-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)