Zimmer Manufacturing Recalls Mini Magna-FX Cann Screws Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws because of insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is related to packaging calibration data rather than a direct structural defect or reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 3,190 units of Mini Magna-FX Cann Screws, which are metallic bone fixation fasteners intended for implantation. The recall covers products under product code HWC with various item numbers, distributed nationwide in the United States.
The recall was initiated due to insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile. The source text does not specify reported illnesses or injuries associated with this recall.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to the recall instructions.
The recalled product
- Product
- Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MI
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,190
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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