Device product
Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Z-0941-2018
Product summary
- Event
- Event 79038
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255
- Official record key
device-enforcement:Z-0941-2018
Official wording
Reason: Inner and outer sterile barriers not fully sealed.
Code information: Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304
Distribution pattern: Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
Derived failure modes
-
Unknown
Inner and outer sterile barriers not fully sealed.