Recall Z-1946-2026— Zimmer, Inc.
Class II · Ongoing
Class II FDA medical device recall by Zimmer, Inc., initiated 2026-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-30
- Firm location
- Warsaw, IN, United States
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.