Z-3245-2024Class II

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

Name: Z-3245-2024 LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Creator: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Published: 2024-09-11
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG (Corp. Hq.) / initiated 2024-09-11 / Open, Classified

FDA source

Waldemar Link GmbH & Co. KG (Corp. Hq.) began a recall of LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 on 2024-09-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3245-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-11
Posted: 2024-09-24
Recalling firm: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Product: LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 32 devices
Distribution: US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Product codes and lots: UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3245-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3245-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-24

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)