CLASS III Device recall · Reported 1 Jan 2020 · FDA Enforcement Report
Integra, Drill CS 5, quick coupling single use recalled
AAP Implantate Ag is recalling Integra, Drill CS 5, quick coupling single use, distributed in Texas. The recall was initiated on 25 Jan 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0731-2020
- FDA event ID
- 84383
- Recalling firm
- AAP Implantate Ag, Berlin
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jan 2019
- FDA classified
- 21 Dec 2019
- Reported
- 1 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Jan 2019 | Recall initiated by company | |
| 21 Dec 2019 | Classified by FDA | +330 days |
| 1 Jan 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products were distributed with the incorrect instructions for use.
Product as listed by the FDA
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Where it was distributed
Texas
Questions about this recall
Is Integra, Drill CS 5, quick coupling single use recalled?
Yes. AAP Implantate Ag recalled Integra, Drill CS 5, quick coupling single use on 25 Jan 2019. The recall is Class III and its status is Terminated. Recall number Z-0731-2020.
Why was it recalled?
Products were distributed with the incorrect instructions for use.
Which lots are affected?
Lot Code: QR0013
Where was it sold?
Texas
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AAP Implantate Ag
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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