Zimmer Manufacturing Recalls 2.7mm Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 60 sterile 2.7mm cortical screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.
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 is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is related to packaging calibration data rather than a direct structural defect or contamination.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 60 units of 2.7mm cortical screws (Product 5, product code HWC) due to insufficient sealer calibration data. The affected items are sterile metallic bone fixation fasteners intended for implantation, used for bone fracture fixation, reconstruction, or traction. The specific item numbers involved are 47482701001, 47482701201, 47482701401, 47482701601, 47482701801, and 47482702001.
The recall is limited to products packaged in the firm's Building II between August 2010 and April 2013. The affected lot numbers are 61920802, 62254418, 61920804, 61920805, 61920806, 62040737, 61920807, 62040736, 61929794, and 62040738. The products were distributed nationwide in the United States.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. The source text does not specify a consumer action for the general public, as these are medical devices intended for professional use.
The recalled product
- Product
- Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 60
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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