Waldem:Link recalls LINK MP Monoblock Hip Stem (Sizes 14-25mm) for potential surgery prolongation due to increased removal force. Affected patients with mobility issues may need procedure adjustments.
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
Waldem:Link is recalling hip stem trial instruments that may require more force to remove, potentially prolonging surgery or needing procedure changes. This affects patients with mobility-limiting conditions, hip fractures, or joint defects.
The hip stem may require more force to remove after impaction, which could prolong surgery time or necessitate surgical procedure modifications. This happens because the stem's design might not release properly under normal surgical conditions.
Patients with mobility-limiting diseases, hip fractures, or joint defects who use these trial hip stems are most at risk. The recall applies to specific sizes (14-25mm) sold to medical facilities.
Check for item number 136-119/00 or UDI-DI 04026575182138 on the product. Lot numbers B922122, B932054, C005071, and C211013 are also affected.
Look for item number 136-119/00 or UDI-DI 04026575182138 on the hip stem instrument.
Discuss whether your hip stem needs to be replaced due to potential increased removal force.
The recall is for increased force required to remove the hip stem after impaction, which may prolong surgery or require procedure changes.
No, but you should contact your surgeon to determine if replacement is needed due to potential increased removal force.
Lot numbers B922122, B932054, C005071, and C211013 are affected.
We’ve drafted a message you can send Waldem:Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2350-2023 — Waldem:Link Waldem:Link Hello, I own a Waldem:Link that is covered by recall Z-2350-2023 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.
