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U.S. Department of Health and Human Services

Class 2 Device Recall 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM

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 Class 2 Device Recall 2.4 VOLT TAP LOCKING SCREW TAP TO 90MMsee related information
Date Initiated by FirmFebruary 25, 2026
Date PostedMarch 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1703-2026
Recall Event ID 98461
Product Classification Tap, bone - Product Code HWX
Product2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Code Information Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
FEI Number 3008812560
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information ContactMona Rehmatullah
610-719-6567
Manufacturer Reason
for Recall		A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
FDA Determined
Cause 2		Process change control
ActionDepuy Synthes initially notified Sales Consultants and Regional Managers on about 02/25/2026, followed by notification of consignees. Consignees were instructed to examine inventory for affected units, quarantine them immediately, and contact Depuy Synthes sales consultant or customer support services to arrange the return/credits for affected units. Additionally, consignees were requested to complete and return the provided Business Response Form as well as notify all applicable personnel within the facility or any consignees if the affected units were further distributed. Consignees were also requested to post the notification in a visible area for awareness.
Quantity in Commerce33 units
DistributionUS Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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