LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

FDA device recall Z-3245-2024 · posted 2024-09-24 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Corp. Hq.)

Reason for recall

Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.

Action taken

An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/11/24 was sent to customers. Actions to be taken by the Customer/User: Please check your inventory for this item and lot combination and return any affected product to LinkBio. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return any affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned, should any affected product be identified. Please return any affected 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

Under Investigation by firm

Status

Open, Classified

Product code

LXH

Quantity affected

32 devices

Distribution

US Nationwide distribution in the states of FL, KS, MI, NJ, VA.

Date initiated

2024-09-11

Date posted

2024-09-24

Location

Hamburg, Germany