Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis impla

FDA device recall Z-2481-2023 · posted 2023-08-29 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

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

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

LXH

Quantity affected

6 units

Distribution

IN,GA, TX

Date initiated

2023-07-26

Date posted

2023-08-29

Location

Norderstedt, Germany