LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Recall
- Recall Number
- Z-3245-2024
- Event Number
- 95344
- Firm
- Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany
- FEI Number
- 3002808472
- Product Code
- LXH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 11, 2024
- Posted
- September 24, 2024
Description
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
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.
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.
US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
32 devices