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Open, Classified

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

FDA Recall Z-1946-2026 · Posted 2026-04-24

Recalling FirmZimmer, Inc.
Recall StatusOpen, Classified
Product CodeJDZ
Date Initiated2026-03-30
Product Quantity66960

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.

Firm Action

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.

Root Cause

Vendor change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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