Waldemar Link recalls LINK MP Monoblock hip stem trial instruments (Size 15) due to potential increased force needed for removal, which may prolong surgery. Affected patients with mobility issues or hip conditions should contact the manufacturer.
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
Waldemar Link is recalling trial hip stem instruments (Size 15) that may require more force to remove after impaction, potentially prolonging surgery. This affects patients with mobility-limiting conditions or hip joint issues who use these instruments during surgery.
The trial hip stem instruments may require more force to remove once impacted in the bone, which could lead to surgery being prolonged or requiring modifications. This happens because the stem's design might not release easily under normal surgical conditions.
Patients with mobility-limiting diseases, hip fractures, or joint defects who undergo surgery using these trial hip stems are most at risk. The recall applies to specific sizes (14-25mm) used in surgical procedures.
Check for the item number 136-115/00 and UDI-DI code 04026575182091 on the instrument. Lot numbers B923004, B932049, C005089, and C211009 are also associated with this recall.
Reach out to Waldemar Link directly to confirm if your instruments are affected and get guidance on next steps.
The recall is due to potential increased force needed to remove the hip stem after impaction, which may prolong surgery or require procedure modifications.
Contact Waldemar Link to determine if your instruments are affected and follow their instructions.
Yes, sizes 14mm to 25mm are included in this recall.
We’ve drafted a message you can send Waldem: Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2346-2023 — Waldem: Link Waldem: Link Hello, I own a Waldem: Link that is covered by recall Z-2346-2023 from Waldem: Link. 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.
