Recall Z-2481-2023 ยท LXH Orthopedic Manual Surgical Instrument
Waldemar Link GmbH & Co. KG (Mfg Site)
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
| Date | Aug 29, 2023 (initiated Jul 26, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | LinkBio Corp.(US Importer) issued Urgent: Medical Device Recall letter via email on July 27, 203 to US Distributors . Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints |
| Quantity | 6 units |
| Distribution | IN,GA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.