Device product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Z-0531-2026
Product summary
- Event
- Event 97877
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0531-2026
Official wording
Reason: The impacted lot may not meet the required tensile strength specification.
Code information: UDI/DI 05414734007276, Lot Numbers: T2502257, exp. 20280128; T2505144, exp. 2028.04.11
Distribution pattern: US
Derived failure modes
-
Potency or specification failure
may not meet the required tensile strength specification