Zimmer Biomet Recalls Mislabeled Periarticular Locking Plate System Screws
Zimmer Biomet is recalling 400 units of Periarticular Locking Plate System screws because the package labels did not match the product contents.
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, which typically indicates a moderate risk. The hazard is a labeling error where the package contents did not match the label, a common issue in medical device recalls that is generally considered a moderate risk if no specific injury is reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 400 units of the Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length and the 2.4mm Locking Screw 14 mm Length. These medical devices are indicated for temporary internal fixation and stabilization of osteotomies and fractures.
The recall was initiated because the product on the package label did not match the product inside the package. Specifically, labels for part number 00-2359-058-35 (3.5mm Locking Screw 58mm Length, lot 62918019) were found on packages containing part number 00-2359-014-24 (2.4mm Locking Screw 14mm Length, lot 62896038).
The affected products were distributed worldwide, including in the United States and various international countries. Healthcare providers and patients should verify the part numbers and lot numbers of their devices against the recall information provided by the manufacturer.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 400
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 (3)
- Item 00-2359-058-35
- Lot 62918019 PERI LOCKING SCREW 3.5MM Item 00-2359-014-24
- Lot 62896038 PERI LOCKING SCREW 2.4MM
Distribution
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