TriMed recalls specific olecranon hook plates due to potential unqualified modifications to angled holes, which may affect bone fixation safety. Affected units include Lot #110631.
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
TriMed is recalling certain olecr:ancon hook plates that may have unqualified modifications to their angled holes. This could lead to improper bone fixation during surgery, risking complications for patients.
The angled hole in the bone plate may have been modified without proper qualification, potentially causing improper alignment or stability during surgery. This could lead to complications like improper bone fixation or surgical failure.
Patients who received the recalled TriMed Olecranon Hook Plate (Lot #110631) for surgical use are most at risk. Medical professionals using this specific model for procedures may also be affected.
Check for the model number OHOOKL-6 on the product label. The specific lot number 110631 is associated with this recall.
Look for the model number OHOOKL-6 and lot number 110631 on the product.
The recall indicates potential unqualified modifications to the angled hole, 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.
Check for the model number OHOOKL-6 and lot number 110631 on the product label.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2020 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-0366-2020 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.
