Howmedica Osteonics Corp. has recalled one unit of its Custom Made Device - GMRS Extension Piece 40MM LEFT, 35 Deg EXT Rotated Tabs. This patient-specific medical device was supplied for a surgical procedure but did not match the original design proposal intended for the patient. Because this was a custom, one-of-a-kind device for an international procedure, the impact is limited to a single patient case.
The device failed to meet the specified design requirements for the intended patient, which could lead to surgical delays or the need for revision if the mismatch was not identified prior to or during the procedure.
Manufacturer or Healthcare Consultation
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.
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Sources: FDA iRES · Raw API Response
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