Zimmer Manufacturing Recalls Sterile Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 109 sterile 3.5mm cortical screws due to 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 109 units of sterile 3.5mm cortical screws (product code HWC) distributed nationwide in the United States. The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013.
The affected products are metallic bone fixation fasteners intended for implantation to fix bone fractures or for bone reconstructions. The specific item numbers involved include 47234801435, 47234801635, 47234806535, 47234807035, 47234807535, 47234808035, 47234808535, and 47234809035. The recall covers specific lot numbers including 62230449, 62081271, 62133855, 62159156, 62047629, 62127760, 61903333, 62261628, 61830478, 61830479, 62138082, 62230452, 61800380, and 61800381.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these items.
The recalled product
- Product
- Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035 3.5MM CORT SCR X 70MM 47234807535 3.5MM CORT SCR X 75MM 47234808035 3.5MM
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 109
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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