Zimmer Manufacturing Recalls Sterile Intramedullary Fixation Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 1,394 sterile intramedullary fixation rods and reconstruction 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. The hazard involves insufficient sealer calibration data, which is a quality control issue that could potentially affect sterility, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 1,394 units of sterile intramedullary fixation rods and reconstruction screws. The recall is 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 recalled items include various item numbers of RECON SCREW LG 5.5MM DIA under product code HSB. These devices are intended to be implanted in the medullary canal of long bones for the fixation of fractures. The products were distributed nationwide in the United States.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the recall and potential replacement of the affected devices.
The recalled product
- Product
- Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 225207555 RECON SCREW LG 5.5MM DIA 225208055 RECON SCREW LG 5.5MM DIA 225208555 RECON SCREW LG 5.5MM DIA 225209055 RECON SCREW LG 5.5MM DIA 225209555 REC
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 1,394
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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