Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catal
- Recall date
- 2026-05-06
- Brand
- Zimmer, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Recommended action
What to do
66960
Product description
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.