Device product
Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640 00877001740 00877001840 00877001940 00877002040 00877002140 00877002240 00877002340
Z-0334-2020
Product summary
- Event
- Event 83962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,459,583 total devices
- Official record key
device-enforcement:Z-0334-2020
Official wording
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Code information: All products manufactured prior to January 2014.
Distribution pattern: Distributed nationwide.
Derived failure modes
-
Unknown
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).