Device recall: INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Class III FDA enforcement event 84383. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Products were distributed with the incorrect instructions for use.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
AAP Implantate Ag started this device recall on 25 Jan 2019. The firm address in the FDA record is in Berlin. FDA put the recall in Class III. FDA event 84383 has 2 product records. The first FDA enforcement report date is 1 Jan 2020. The record gives the status Terminated, with the termination date 30 Sep 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Texas
Recalling firm
AAP Implantate Ag, Berlin, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0731-2020 | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | 2 units | Class III | Terminated | 1 Jan 2020 |
| Z-0732-2020 | INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 | 7 units | Class III | Terminated | 1 Jan 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class III
- 6%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 Nov 2019 | aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 | Device | Class II | 1 |
| 11 Jan 2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the i | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0731-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84383. https://recallregister.com/fda/iii/84383/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Texas
- What quantity of product is in FDA event 84383?
- The event has 2 product records. The first record gives this quantity:
2 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 6% of the 968 device events that started in 2019 are in Class III.