Use cautionMedical device recall · FDA · Published July 26, 2023
Link OptiStem Rasp Handle Recall: Crack Risk During Knee Surgery
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
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Contact the company
📍Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site)Oststr. 4-10 · Norderstedt, Germany
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/57609-link-optistem-rasp-handle-recall-crack-risk-during-knee-surgery.
“Link OptiStem Rasp Handle Recall: Crack Risk During Knee Surgery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/57609-link-optistem-rasp-handle-recall-crack-risk-during-knee-surgery. Based on FDA recall #Z-2481-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2481-2023%22&limit=1).
The FDA announced on July 26, 2023, that Waldemar Link GmbH & Co. KG is recalling the Link OptiStem Rasp Handle-Used with the OptiStem Rasp due to a potential weld crack. This defect may cause the frontal sleeve to fracture during surgery.
How to tell if you have it
Brand: Waldemar Link
Product: Link OptiStem Rasp Handle-Used with the OptiStem Rasp
Item Number: 17-5220/01
UDI-DI: 04026575284658
Lot Codes: C010108, C151519
Distribution: Indiana, Georgia, Texas
Units affected: 6
The hazard
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 but would need to be pulled out by a clamp, leading to a prolongation of surgery or modified surgery.
Context
GovInfoNow's records show Waldemar Link GmbH & Co. KG has issued 21 other recalls since December 4, 2018. Recent brand recalls include the Endo-Model Tibial Plateau Recall on July 6, 2026, and the Embrace Drill Tower Wedged (25mm) Recall on February 11, 2026. Other recent recalls of similar products include the Zimmer Off-Axis Shoulder System Recall (May 20, 2026), the Olympus PK Cutting Forceps Recall (February 25, 2026), and the Olympus HALO PKS Cutting Forceps Recall (February 25, 2026).
How to tell if you have this one
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.
Brand
Waldemar Link
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the lot code and item number on the handle to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “IN,GA, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, Indiana, Texas.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2481-2023 (July 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2481-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.