LINK Universal Handle, with quick coupling, Stainless… recallZ-3245-2024 · Waldemar Link GmbH & Co. KG (Corp. Hq.) · initiated Sep 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Corp. Hq.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] for any questions.
Recall details
- Recall number
- Z-3245-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2024
- Posted by the FDA
- Sep 24, 2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Quantity
- 32 devices
- Product code
- LXH
- Distribution
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Product description
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Code information (models, lots, serial numbers)
UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LCU Hip System - Instruments 130-394/01WALDEMAR LINK GmbH & Co. KG · Orthopedic manual surgical instrument1 recall5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page