Synthes 2.4 VOLT TAP LOCKING SCREW TAP Recall Due to Thread Issue

Source: FDA · United States

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Synthes (USA) Products LLC is recalling 77 units of the 2.4 VOLT TAP LOCKING SCREW TAP 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 14, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 initiated a voluntary recall because of a full lot swap that resulted in the bone taps having an incorrect thread. This issue involves the mixing of lots for the VOLT Locking Screw Tap and Cortical Screw Tap.

Which Products Are Affected

The affected product is the 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM, with Part Number: 03.424.124-US. The recall includes 77 units, specifically Lot Number: 68900P9, and GTIN: 10886982335944. Distribution occurred nationwide in the United States, including 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. The official recall number is Z-1702-2026.

What You Should Do

Consumers, likely healthcare providers, should follow the initial firm notification via letter and contact Synthes (USA) Products LLC at their address: 1301 Goshen Pkwy, West Chester, PA 19380-5986, for information on returns or further instructions related to this recall.

Why This Matters

This recall highlights potential risks with medical devices due to manufacturing errors, which could affect surgical procedures and patient safety in the United States.

Source

Attribution: FDA Recall Notice, Event ID: 98461, Recall Number: Z-1702-2026. For more information, visit the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Synthes (USA) Products LLC is recalling 77 units of the 2.4 VOLT TAP LOCKING SCREW TAP 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.