Device product
Bone Dowell Harvest Tubes
Z-2059-2017
Product summary
- Event
- Event 77113
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
device-enforcement:Z-2059-2017
Official wording
Reason: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Code information: Part Number: 900738 Lot Number (LN): 889990
Distribution pattern: No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND
Derived failure modes
-
Labeling or packaging
mislabeled