FDA Medical Device Recalls (openFDA)
AAP Implantate Ag: INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
- Recall number
- Z-0731-2020
- Recalling firm
- AAP Implantate Ag
- Product
- INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
- Status
- Terminated
- Initiated
- 2019-01-25
- Posted
- not on file
- Terminated
- 2024-09-30
- Reason
- Products were distributed with the incorrect instructions for use.
- 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
- 2 units
- Distribution
- Texas
- Lot, serial or model codes
- Lot Code: QR0013
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3001406084
- Firm city
- Berlin
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28