Zimmer Manufacturing Recalls 3.5mm Cortical Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 99 units of 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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a voluntary precautionary measure regarding packaging calibration.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 99 units of 3.5mm cortical screws (Product 8) 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 sterile.
The recalled items include various lengths of 3.5mm cortical screws, specifically item numbers 47483501201, 47483501401, 47483501601, 47483501801, 47483503601, and 47483507501. These devices are intended for the fixation of bone fractures, bone reconstructions, or as guide pins for other implants. The specific lot numbers associated with this recall are 61894346, 61892658, 61892659, 61894347, 61888124, 61614768, 62036752, 62036753, and 62036754.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Manufacturing B.V. for further instructions on the recall process.
The recalled product
- Product
- Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 47483501801 3.5MM CORT. SCREW 18MM LN 47483503601 3.5MM CORT. SCREW 36MM LN
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 99
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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