2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Summary
The FDA issued a Class II for 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. by Synthes (USA) Products LLC. Reason: 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 havin.
Details
Source
Device Recall
External ID
Z-1703-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Lot/Code Info: Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.
Quantity Affected: 33 units
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.
Distribution
US 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-25
Company
West Chester, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Synthes (USA) Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synthes (USA) Products LLC have FDA actions?
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1703-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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