Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the… — Class II medical device recall Z-2481-2023
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2023-09-06, distributed in GA, IN, TX. A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further i
| Recall number | Z-2481-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany |
| Recall initiated | 2023-07-26 |
| Classified | 2023-08-29 |
| Reported by FDA | 2023-09-06 |
| Distributed | GA, IN, TX |
| Quantity | 6 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 04026575284658 |
| Lot numbers | C010108, C151519 |
| Model numbers | 17-5220/01 |
Product
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2481-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.