FDA Recall
Terminated
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Recall: Z-0732-2020
·
Initiated January 25, 2019
Recall
- Recall Number
- Z-0732-2020
- Event Number
- 84383
- Firm
- AAP Implantate Ag Lorenzweg 5 Berlin Germany
- FEI Number
- 3001406084
- Product Code
- HTW
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 25, 2019
- Terminated
- September 30, 2024
Description
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Reason
Products were distributed with the incorrect instructions for use.
Action
The firm notified its sole consignee about the labeling issue by email on 01/25/2019 and provided the correct instructions for use.
Distribution
Texas
Quantity
7 units