Zimmer, Inc.: Mixer, Cement, For Clinical Use
Recall Summary Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) used in clinical settings because the package seal may be incomplete, wrinkled, or peeling. The compromised seal could allow contamination of the sterile product, potentially leading to extended surgery time or infection requiring additional surgical intervention. The product was distributed nationwide across the U.S. and internationally to Canada, Australia, New Zealand, Malaysia, Chile, and EMEA countries.
- Recalling firm
- Zimmer, Inc.
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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 Canada, Australia, New Zealand, Malaysia, EMEA, Chile.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/78468c22-237f-4df1-aac7-4a61b1387cc6