Device product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Z-3245-2024
Product summary
- Event
- Event 95344
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 devices
- Official record key
device-enforcement:Z-3245-2024
Official wording
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.
Code information: UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135
Distribution pattern: US Nationwide distribution in the states of FL, KS, MI, NJ, VA.
Derived failure modes
-
Unknown
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.