Depuy Synthes ATTUNE Revision Hinge Knee Inserts Recall

Source: FDA · Minnesota, North Carolina, Texas

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

DePuy (Ireland) is recalling 160 units of ATTUNE Revision Hinge Knee Hinge Insert Components due to potential sterility compromise from adhered packaging.

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

This notice was issued by FDA on August 7, 2026 and geographically references Minnesota, North Carolina, Texas. 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, MedicalDevices.

What Happened

DePuy (Ireland) initiated a voluntary recall of certain ATTUNE Revision Hinge Knee Hinge Insert Components after the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Which Products Are Affected

The recall covers 40 specific Depuy Synthes ATTUNE KNEE SYSTEM REVISION HINGE INSERT models with part numbers including 151730410, 151730412, 151730414, 151730416, 151730418, 151730420, 151730422, 151730424, 151730426, 151730408, 151730510, 151730512, 151730514, 151730516, 151730518, 151730520, 151730522, 151730524, 151730526, 151730508, 151730710, 151730712, 151730714, 151730716, 151730718, 151730720, 151730722, 151730724, 151730726, 151730708, 151730810, 151730812, 151730814, 151730816, 151730818, 151730820, 151730822, 151730808, 151730824, and 151730826. A total of 160 units distributed to Minnesota, North Carolina, and Texas are affected. Associated GTINs and lot numbers are detailed in FDA recall Z-2617-2026.

What You Should Do

No specific consumer instructions are provided in the recall notice. The action is classified as Class II and was initiated voluntarily by the firm.

Why This Matters

The recall involves medical devices distributed in three U.S. states where compromised sterility could affect product safety.

Source

FDA recall number Z-2617-2026, report date 20260708.

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
DePuy (Ireland) is recalling 160 units of ATTUNE Revision Hinge Knee Hinge Insert Components due to potential sterility compromise from adhered packaging.
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 Minnesota, North Carolina, Texas. 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.