Device product

QuickGraft¿ Model # 430PST

Z-2548-2019

August 15, 2019

Class II

Product summary

Firm: Musculoskeletal Transplant Foundation, Inc.
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
reason.no_named_rule · v1.0.0

Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.