Device product
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Z-0074-2022
Product summary
- Event
- Event 88722
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0074-2022
Official wording
Reason: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Code information: Lot Number: J6304Z GTIN: 10603295057642
Distribution pattern: US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Derived failure modes
-
Unknown
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery