FDA Medical Device Recalls (openFDA)
AAP Implantate Ag: aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
- Recall number
- Z-1675-2020
- Recalling firm
- AAP Implantate Ag
- Product
- aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
- Status
- Terminated
- Initiated
- 2019-11-28
- Posted
- not on file
- Terminated
- 2025-03-27
- Reason
- The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
- Root cause
- Use error
- Action
- The firm initiated the recall by email on 11/28/2019. The letter explained the reason for recall and requested the following: "Please take the following actions immediately: 1. Please immediately remove all products with the catalog number in question from your warehouse or from affected trays to prevent further use. 2. A confirmation form is enclosed with this letter; please fill in, sign it and return it to us after receiving this information. If you have no affected products, please fill in the confirmation form anyway and fax it to 0049 (0) 30 750 19 111 or email it to incident@aap.de. 3. Please immediately return any products you still have in stock to us. Please ensure that all users of the affected products within your organization and other persons who are affected receive this information via the Field Safety Notice. If products are passed on to third parties, please also send these third parties a copy of the Field Safety Notice or inform our contact. "
- Quantity
- 7 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Lot Numbers: I012, I025, I028
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAD
- 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