Miami Device Solutions recalls right-sided Proximal Humerus Plates (REF MDS130108R) due to risk of improper identification as left side. This affects orthopedic implants used in fracture repairs.
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Miami Device Solutions recalls right-sided Proximal Humerus Plates (REF MDS130108R) because they may be incorrectly identified as left-sided implants. This could lead to improper surgical placement if used in the wrong limb.
The right-sided plates may be misidentified as left-sided implants during surgery. This could cause improper placement if used in the wrong limb, potentially affecting surgical outcomes.
Orthopedic patients who received this specific right-sided plate implant (REF MDS130108R) during surgery. Patients with the same implant model are most at risk.
Check if your implant has the reference number MDS130108R and is labeled as 'Right' for the proximal humerus plate. The lot number PM00208 is also associated with this specific recall.
Check if your implant has the reference number MDS130108R and is labeled as 'Right' for the proximal humerus plate.
The right-sided plates may be incorrectly identified as left-sided implants during surgery, which could lead to improper placement if used in the wrong limb.
The recall record does not specify a remedy or action for affected patients.
Check if your implant has the reference number MDS130108R and is labeled as 'Right' for the proximal humerus plate. The lot number PM00208 is also associated with this specific recall.
We’ve drafted a message you can send Miami Device Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0603-2020 — Miami Device Solutions Miami Device Solutions Hello, I own a Miami Device Solutions that is covered by recall Z-0603-2020 from Miami Device Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
