Zimmer Manufacturing Recalls Interlocking Intramedullary Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 4,752 sterile interlocking intramedullary 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 or injuries. The hazard is a potential loss of sterility due to packaging calibration issues, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 4,752 units of sterile interlocking intramedullary screws (IM screws) in small, medium, and large sizes. 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 identified by product code HSB and specific item numbers, including 225303255, 225303555, 225303755, 225307055, 225302742, 225303242, 225307042, 225302737, and 225303237. These devices are intended to be implanted into the medullary canal of long bones for the fixation of fractures. The recall covers units distributed nationwide in the United States.
The source text does not specify reported illnesses or injuries associated with this recall. The hazard is related to the integrity of the sterile packaging seal, which may be compromised due to the lack of calibration data for the sealing equipment used during the specified period.
The recalled product
- Product
- Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 I
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 4,752
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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