Z-2100-2021 Class II Terminated
FDA device recall Z-2100-2021 was initiated by Stryker Spine on May 18, 2021 and is designated Class II. Reason for recall: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. The recall status is terminated (terminated April 15, 2022). Affected quantity: 559 total.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- May 18, 2021
- Termination Date
- April 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 559 total
Product Description
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Reason for Recall
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Distribution Pattern
US Nationwide Distribution
Code Information
lot A1908003