Z-1675-2020 Class II Terminated
FDA device recall Z-1675-2020 was initiated by AAP Implantate Ag on November 28, 2019 and is designated Class II. 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… The recall status is terminated (terminated March 27, 2025). Affected quantity: 7 units.
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