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
Recall
- Recall Number
- Z-1946-2026
- Event Number
- 98665
- Firm
- Zimmer, Inc.
- FEI Number
- 1000220733
- Product Code
- JDZ
- Status
- Open, Classified
- Root Cause
- Vendor change control
- Initiated
- March 30, 2026
- Posted
- April 24, 2026
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
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
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.
On March 30, 2026, the firm began notifying customers via letters titled "URGENT MEDICAL DEVICE RECALL." Risk Managers were instructed to notify affected personnel and locate and quarantine affected product in inventory. A Zimmer Biomet sales representative may remove and return the affected product on your behalf, or the customer may choose to directly return all affected product from their facility. Surgeons were informed that there are no specific patient-monitoring instructions recommended beyond existing follow up schedules.
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile.
66960