FDA Recall of Synthes 2.4 VOLT(TM) TAP CORTEX SCREW
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,146 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.