Zimmer Manufacturing Recalls Distal Femoral Components Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 945 units of distal femoral components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 945 units of distal femoral components, including distal medial femoral cones and distal posterior/lateral components, under product code HSB. The recall is being conducted 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 recall covers products distributed nationwide in the United States. The specific item numbers affected include 234703104, 234703206, 234703208, 234800504, 234800506, 234800508, 234800510, 234800604, 234800606, 234800608, 234800610, and 234800614. These devices are intended to be implanted as intramedullary fixation rods for the fixation of fractures in long bones.
Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further information regarding the recall and potential replacement or repair options. The FDA has classified this recall as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL…
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 945
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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