Device product
QuickGraft¿ Model # 430PST
Z-2548-2019
Product summary
- Event
- Event 83644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 Qty
- Official record key
device-enforcement:Z-2548-2019
Official wording
Reason: Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
Code information: Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056
Distribution pattern: NY NC LA TX MO OH
Derived failure modes
-
Unknown
Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.