Z-1675-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- November 28, 2019
- Termination Date
- March 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
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.
Distribution Pattern
Worldwide Distribution
Code Information
Lot Numbers: I012, I025, I028