FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Corp. Hq.): LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
- Recall number
- Z-3245-2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.)
- Product
- LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
- Status
- Open, Classified
- Initiated
- 2024-09-11
- Posted
- 2024-09-24
- Terminated
- not on file
- Reason
- 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.
- 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 complaints@linkbio.com for any questions.
- Quantity
- 32 devices
- Distribution
- US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
- Lot, serial or model codes
- UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3002808472
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28