FDA recall Z-1675-2020

Product

aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00

Reason for recall

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.

Distribution

Worldwide Distribution

Key facts

Status

Terminated

Initiation date

2019-11-28

Report date

2020-04-15

Termination date

2025-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1675-2020