Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011

FDA device recall Z-1946-2026 · posted 2026-04-24 · Open, Classified

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

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

Status

Open, Classified

Product code

JDZ

Quantity affected

66960

Distribution

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 Ca

Date initiated

2026-03-30

Date posted

2026-04-24

Location

Warsaw, IN