Zimmer, Inc. has recalled 76 units of the NexGen LPS Flex Knee Prosthesis (Model 00-5962-042-10) because the labels contain conflicting information about plate compatibility. The top of the label specifies use with plates 7, 8, 9, and 10, while the translation section of the same label incorrectly specifies plates 5 and 6. To date, no incidents or injuries have been reported.
The conflicting labeling information could lead a surgical team to select or use incompatible plates during a knee replacement procedure. This discrepancy could result in surgical delays, improper fit of the implant, or the need for additional corrective surgery.
Labeling discrepancy between compatibility statements on top of the label and the translations section.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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