FDA Recall of Synthes 2.4 VOLT(TM) TAP CORTEX SCREW

Source: FDA · United States

The FDA has announced a recall of 33 units of the 2.4 VOLT(TM) TAP CORTEX SCREW due to an incorrect thread from a lot swap, affecting nationwide distribution in the U.S.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 16, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Synthes (USA) Products LLC is recalling the 2.4 VOLT(TM) TAP CORTEX SCREW due to a full lot swap that resulted in the bone taps having an incorrect thread.

Which Products Are Affected

The affected product is the 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM, with Part Number: 03.424.126-US. It includes GTIN: 10886982335951 and Lot Number: 68982P8. A total of 33 units are affected, distributed nationwide in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI.

What You Should Do

Consumers should contact Synthes (USA) Products LLC for instructions, as the recall was initiated via letter. For returns or refunds, reach out to the firm at their address: 1301 Goshen Pkwy, West Chester, PA 19380-5986.

Why This Matters

This recall involves medical devices with potential for incorrect use due to threading issues, which could affect patient safety in surgical procedures.

Source

FDA recall notice Z-1703-2026. Attribution: FDA (U.S. Food and Drug Administration). For more information, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls/.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has announced a recall of 33 units of the 2.4 VOLT(TM) TAP CORTEX SCREW due to an incorrect thread from a lot swap, affecting nationwide distribution in the U.S.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.