Recall Z-2548-2019
Musculoskeletal Transplant Foundation, Inc. · initiated August 15, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QuickGraft Model # 430PST
Codes / lots: Serial # 00319004921075 00319004921073 00319007681048 00319014411085 00618052231059 03319006511040 03319009191029 03319019231072 03519018121056
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.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-2548-2019
- Initiated
- August 15, 2019
- Terminated
- July 1, 2020
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Quantity
- 9 Qty
- Distribution
- NY NC LA TX MO OH
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc., Edison, NJ