Recall Z-1675-2020— AAP Implantate Ag

Name: FDA recall Z-1675-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-28

Class II · Terminated

Class II FDA medical device recall by AAP Implantate Ag, initiated 2019-11-28, terminated 2025-03-27. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: AAP Implantate Ag
Classification: Class II
Status: Terminated
Initiated: 2019-11-28
Terminated: 2025-03-27
Firm location: Berlin, N/A, Germany

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.