FDA recall Z-2548-2019

Musculoskeletal Transplant Foundation, Inc. · Class II · device

Product

QuickGraft¿ Model # 430PST

Reason for recall

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

Distribution

NY NC LA TX MO OH

Key facts

Status
Terminated
Initiation date
2019-08-15
Report date
2019-10-02
Termination date
2020-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Edison, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2019