Waldemar Link recalls OptiStem Rasp Handles used in knee surgery due to potential crack causing surgery delays or modifications. Affected items have specific lot codes and item numbers.
A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery
Waldemar Link recalls OptiStem Rasp Handles used in knee surgery because a crack in the handle weld could cause the frontal sleeve to fracture during removal, potentially prolonging surgery or requiring surgical changes. This is a serious risk for patients undergoing knee replacement procedures.
A crack in the weld of the rasp handle could cause the frontal sleeve to fracture when the rasp is pulled out. This might require the surgeon to prolong the surgery or make changes to the procedure, increasing risks for patients.
Patients undergoing total knee arthroplasty surgery who use the recalled OptiStem Rasp Handle are affected. Surgeons and surgical teams are most at risk due to potential surgery delays or modifications.
The recalled item is the OptiStem Rasp Handle used with the OptiStem Rasp for knee surgery. Lot codes C010108 and C151519, and item number 17-5220/01 are associated with this recall.
Identify the lot code and item number on the handle to confirm if it's affected.
Yes, a crack in the handle weld could cause the frontal sleeve to fracture during removal, potentially prolonging surgery or requiring surgical changes.
Check the lot code and item number on the handle to see if it's affected. If it is, contact Waldemar Link for further instructions.
The recalled handle has lot codes C010108 or C151519 and item number 17-5220/01.
We’ve drafted a message you can send Waldemar Link to request your refund or repair — edit it as you like.
Subject: Recall Z-2481-2023 — Waldemar Link Waldemar Link Hello, I own a Waldemar Link that is covered by recall Z-2481-2023 from Waldemar 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.
