Recall Z-2548-2019 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Musculoskeletal Transplant Foundation, Inc.
QuickGraft Model # 430PST
| Date | Aug 15, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by 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 |
| Quantity | 9 Qty |
| Distribution | NY NC LA TX MO OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181633 | MTF Pre-Sutured Tendon Musculoskeletal Transplant Foundation, Mar 15, 2019 |