Brand Name: Disposable Mixing Bowls with Spatula recallZ-1946-2026 · Zimmer, Inc. · initiated Mar 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Vendor change control
What the company is doing
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.
Recall details
- Recall number
- Z-1946-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 30, 2026
- Posted by the FDA
- Apr 24, 2026
- Recalling firm
- Zimmer, Inc.
- Quantity
- 66960
- Product code
- JDZ
- 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.
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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Lot Code: Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301014(10)85390029 ; Individual UDI (01)00889024376564(17)301014(10)85390029 ; Lot Number 85390029 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301103(10)85682882 ; Individual UDI (01)00889024376564(17)301103(10)85682882 ; Lot Number 85682882 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)301001(10)85390028 ; Individual UDI (01)00889024376564(17)301001(10)85390028 ; Lot Number 85390028 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300422(10)82395239 ; Individual UDI (01)00889024376564(17)300422(10)82395239 ; Lot Number 82395239 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300423(10)82395240 ; Individual UDI (01)00889024376564(17)300423(10)82395240 ; Lot Number 82395240 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300929(10)85390027 ; Individual UDI (01)00889024376564(17)300929(10)85390027 ; Lot Number 85390027 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300924(10)85390026 ; Individual UDI (01)00889024376564(17)300924(10)85390026 ; Lot Number 85390026 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300415(10)82395238 ; Individual UDI (01)00889024376564(17)300415(10)82395238 ; Lot Number 82395238 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300922(10)85390025 ; Individual UDI (01)00889024376564(17)300922(10)85390025 ; Lot Number 85390025 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300826(10)85390022 ; Individual UDI (01)00889024376564(17)300826(10)85390022 ; Lot Number 85390022 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300918(10)85390024 ; Individual UDI (01)00889024376564(17)300918(10)85390024 ; Lot Number 85390024 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)300722(10)85390023 ; Individual UDI (01)00889024376564(17)300722(10)85390023 ; Lot Number 85390023 Model No. 00504901100 ; 20-Pack UDI (01)00889024379718(17)310122(10)86970970 ; Individual UDI (01)00889024376564(17)310122(10)86970970 ; Lot Number 86970970
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 5049-11Zimmer, Inc. · MIXER, CEMENT, FOR CLINICAL USE1 recall389 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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