FDA Device recall Z-1675-2020
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
- FDA Device
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 by Aap Implantate Ag, citing 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 abrasi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1675-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-28 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aap Implantate Ag |
| Distribution | n/a |
Product
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
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.
Identifiers
| code_info | Lot Numbers: I012, I025, I028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.