FDA Enforcement
Class II
Ongoing
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Recall: Z-2171-2021
·
Reported August 11, 2021
Enforcement
- Recall Number
- Z-2171-2021
- Event ID
- 88240
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 11, 2021
- Initiation Date
- May 27, 2021
- Classification Date
- July 30, 2021
- Address
- Bohnackerweg 1, Selzach, N/A, Switzerland
Description
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Reason
The devices have a different inner diameter than the diameter specified on the outer box label.
Code Info
GTIN 04546540715357, Lot Number K03CC4F
Distribution
US Nationwide Distribution
Quantity
242