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Terminated

QuickGraft Model # 430PST

FDA Recall Z-2548-2019 · Posted None

Recalling FirmMusculoskeletal Transplant Foundation, Inc.
Recall StatusTerminated
Product CodeGAT
Date Initiated2019-08-15
Date Terminated2020-07-01
Product Quantity9 Qty

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.

Firm Action

You may choose to add the additional label to the unit(s), this may be completed by an appropriate Sales Representative or hospital staff. Or, you may choose to have the unit(s) returned to MTF for the labelling correction

Root Cause

Under Investigation by firm

Distribution Pattern

NY NC LA TX MO OH

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181633MTF Pre-Sutured TendonMusculoskeletal Transplant Foundation · 2019-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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