Date Initiated by Firm |
May 12, 2020 |
Create Date |
July 04, 2020 |
Recall Status1 |
Terminated 3 on March 19, 2021 |
Recall Number |
Z-2500-2020 |
Recall Event ID |
85789 |
Product Classification |
Impactor - Product Code HWA
|
Product |
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 |
Code Information |
LOT: XS1920458A |
Recalling Firm/ Manufacturer |
XTANT Medical 664 Cruiser Ln Belgrade MT 59714-9719
|
For Additional Information Contact |
Michele Dolan 406-388-0480 Ext. 1127
|
Manufacturer Reason for Recall |
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.
|
FDA Determined Cause 2 |
Process design |
Action |
On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices.
On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers. |
Quantity in Commerce |
4 units |
Distribution |
AZ, TX and WV. |
Total Product Life Cycle |
TPLC Device Report
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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