Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 30, 2026 |
| Reported | May 06, 2026 |
| Recalling firm | Zimmer, Inc. |
| Country / region | United States IN |
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.
Affected products
- Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product De
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