Date Initiated by Firm |
December 22, 2023 |
Date Posted |
February 09, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1067-2024 |
Recall Event ID |
93853 |
510(K)Number |
K042125
|
Product Classification |
Filler, bone void, calcium compound - Product Code MQV
|
Product |
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) |
Code Information |
UDI-DI: W4184227005T0473
Donor Lots 00322029241137 and 00322039641144 |
Recalling Firm/ Manufacturer |
Musculoskeletal Transplant Foundation, Inc. 125 May St Ste 300 Edison NJ 08837-3264
|
For Additional Information Contact |
MTF Customer Service Department 800-433-6576
|
Manufacturer Reason for Recall |
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm notified their distributor of the issue during a meeting on December 22, 2023. A notification letter was also issued to the distributor. If the device/tissue was transplanted, no further action is warranted. However, if the device/tissue is still available in the customer's inventory, the unit shall be returned to Spineology, the distributor.
Should you have any questions, please contact the firm at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org. |
Quantity in Commerce |
50 |
Distribution |
Product was distributed to Minnesota. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = MQV and Original Applicant = MUSCULOSKELETAL TRANSPLANT FOUNDATION
|