Device product
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Z-0534-2025
Product summary
- Event
- Event 95638
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 kits
- Official record key
device-enforcement:Z-0534-2025
Official wording
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Code information: Lot number 24ABO552, exp. 9/30/2025, UDI-DI each 10195327198930, UDI-DI case 40195327198931.
Distribution pattern: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Derived failure modes
-
Unknown
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.