Z-0731-2020Class III

INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453

Name: Z-0731-2020 INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Creator: AAP Implantate Ag
Published: 2019-01-25
License: https://open.fda.gov/license/

AAP Implantate AG / initiated 2019-01-25 / Terminated / root cause: labeling and UDI

FDA source

AAP Implantate Ag began a recall of INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 on 2019-01-25. FDA classified it as Class III and gives the reason as "Products were distributed with the incorrect instructions for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0731-2020
Classification: Class III
Status: Terminated
Initiated: 2019-01-25
Posted: 2019-12-22
Terminated: 2024-09-30
Recalling firm: AAP Implantate AG
Product: INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Product code: HTW Bit, Drill
Reason for recall: Products were distributed with the incorrect instructions for use.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.
Quantity in commerce: 2 units
Distribution: Texas
Product codes and lots: Lot Code: QR0013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-21
Z-0732-2020	Class III	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-21

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)