CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products

Synthes (USA) Products is recalling 2.4 Volt(tm) Tap Cortex Screw To, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.

Quantity recalled33 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1703-2026
FDA event ID: 98461
Recalling firm: Synthes (USA) Products, West Chester, PA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Feb 2026
FDA classified: 30 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Feb 2026	Recall initiated by company
30 Mar 2026	Classified by FDA	+33 days
8 Apr 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Florida Indiana Louisiana Maryland Minnesota North Carolina New Jersey Ohio Oklahoma Oregon Pennsylvania Tennessee Texas Utah Virginia Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Part Number: 03.424.126-US. GTIN: 10886982335951. Lot Number: 68982P8.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98461

This product is part of a recall event; the main page for the event is 2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products.

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026	CLASS II	2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide

More recalls from Synthes (USA) Products

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Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products	Synthes (USA) Products	Other	Nationwide
29 Oct 2025Device	CLASS II	Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled	Synthes (USA) Products	Packaging Defects	Nationwide
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