Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with ten complaints but no reported hospitalizations or confirmed adverse outcomes. The source states potential harms are "clinically insignificant extension of surgery or infection," which is a theoretical or minor risk scenario. This meets the Moderate criterion for low-risk or precautionary recalls.
Plain-English summary
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula, Model 00-5049-011-00, distributed nationwide across the US and internationally. The recall affects 66,960 units with multiple lot numbers.
Ten complaints have been received identifying package seal issues at the time of use, including incomplete seals, wrinkles in the seals, or peeling seals. A compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Healthcare facilities and users in possession of affected units should contact Zimmer, Inc. for further guidance or replacement product. The affected lot numbers are 85390029, 85682882, 85390028, 82395239, 82395240, 85390027, 85390026, 82395238, 85390025, 85390022, 85390024, 85390023, and 86970970.
The recalled product
- 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
- Manufacturer
- Zimmer, Inc.
- Hazard
- sterile-barrier-compromise
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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