Recall Z-3245-2024 ยท LXH Orthopedic Manual Surgical Instrument
Waldemar Link GmbH & Co. KG (Corp. Hq.)
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
| Date | Sep 24, 2024 (initiated Sep 11, 2024) |
| Status | Open, Classified |
| 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 a |
| Quantity | 32 devices |
| Distribution | US Nationwide distribution in the states of FL, KS, MI, NJ, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.