Official recall record
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total kn
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-07-26
- Country of alert
- Germany
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04026575284658
- Brand on record
- Waldemar Link GmbH & Co. KG (Mfg Site)
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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