Zimmer Biomet Recalls Mislabeled Cannulated Screws Due to Labeling Error
Zimmer Biomet is recalling six 6.5mm x 125mm x 16mm Cannulated Screws because they were mislabeled as 3.5mm x 24mm Cortical Locking screws.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard is a minor labeling error without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling six units of 6.5mm x 125mm x 16mm Cannulated Screws, Item Number 110009948. The recall is due to a labeling error where the product was incorrectly labeled as 3.5mm x 24mm Cortical Locking screws.
The affected product is part of the 6.5/8.0mm Cannulated Screw System, which is used for various orthopedic procedures including slipped capital femoral epiphysis, pediatric femoral neck fractures, and fixation of the pelvis and iliosacral joint. The specific lot number is 120910.
The recall is limited to Canada. Healthcare providers and patients should verify the labeling of their cannulated screws against the item number and dimensions to ensure they are not using the mislabeled product.
The recalled product
- Product
- 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 6
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 (1)
- Lot: 120910
Distribution
Distribution scope not specified by the agency.
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