Z-1703-2026Class II

2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US

Name: Z-1703-2026 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US
Creator: Synthes (USA) Products LLC
Published: 2026-02-25
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2026-02-25 / Open, Classified

FDA source

Synthes (USA) Products LLC began a recall of 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US on 2026-02-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1703-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-25
Posted: 2026-03-30
Recalling firm: Synthes (USA) Products LLC
Product: 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
Product code: HWX Tap, Bone
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 root cause: Process change control
Action: Depuy 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 commerce: 33 units
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.
Product codes and lots: Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-30
Z-1703-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-30

Product code HWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)