Device product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Z-0532-2026
Product summary
- Event
- Event 97877
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 18 units
- Official record key
device-enforcement:Z-0532-2026
Official wording
Reason: The impacted lot may not meet the required tensile strength specification.
Code information: UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
Distribution pattern: US
Derived failure modes
-
Potency or specification failure
may not meet the required tensile strength specification