Date Initiated by Firm |
July 26, 2023 |
Date Posted |
August 29, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2481-2023 |
Recall Event ID |
92839 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
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 |
Code Information |
UDI-DI: 04026575284658
Lot Codes: C010108, C151519 |
Recalling Firm/ Manufacturer |
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
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For Additional Information Contact |
SAME US 494053995150
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Manufacturer 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
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FDA Determined Cause 2 |
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@linkbio.com for any questions. |
Quantity in Commerce |
6 units |
Distribution |
IN,GA, TX |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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