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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Manual Surgical Instrument Impactor

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 Class 2 Device Recall Orthopedic Manual Surgical Instrument Impactorsee related information
Date Initiated by FirmMay 12, 2020
Create DateJuly 04, 2020
Recall Status1 Terminated 3 on March 19, 2021
Recall NumberZ-2500-2020
Recall Event ID 85789
Product Classification Impactor - Product Code HWA
ProductIrix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Code Information LOT: XS1920458A
FEI Number 3005031160
Recalling Firm/
Manufacturer		 XTANT Medical
664 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information ContactMichele 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
ActionOn 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 Commerce4 units
DistributionAZ, TX and WV.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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