TriMed recalls Dorsal Wrist Hook Plate model WHD-4 due to potential structural issues from design control process failures. Affected units include specific lot numbers sold in Santa Clarita, CA.
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
TriMed is recalling its Dors:al Wrist Hook Plate model WHD-4 because design flaws might cause the device to become structurally weak. This could lead to injury if the plate fails during use.
The device may have structural integrity issues because the company didn't properly follow design control processes during development. This could mean the plate might not hold properly during medical use, potentially causing injury.
Patients using the TriMed Dorsal Wrist Hook Plate for medical procedures are affected. Those with the specific lot numbers (28884-28887) from Santa Clarita, CA are most at risk.
Check for the model number WHD-4 on the TriMed Dorsal Wrist Hook Plate. Look for lot numbers 28884 through 28887 on the packaging or label from Santa Clarita, CA.
Identify the model number (WHD-4) and lot numbers (28884-28887) on the device packaging or label.
The recall states the device may have structural integrity issues due to design control process failures, so it is not recommended for use until the recall is addressed.
The recall does not specify a remedy, so contact TriMed directly for guidance on next steps.
Check for model number WHD-4 and lot numbers 28884-28887 on the packaging or label from Santa Clarita, CA.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0118-2020 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-0118-2020 from TriMed. 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.
