Recall of Depuy Synthes ATTUNE Revision Hinge Femoral Device

Source: FDA · United States

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The FDA has announced a voluntary recall of 3 units of Depuy Synthes ATTUNE Revision Hinge Femoral device due to potential sterility issues from packaging problems.

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

This notice was issued by FDA on May 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

The recall was initiated because the external sterile packaging was found adhered to the internal sterile packaging, potentially compromising the sterility of the product.

Which Products Are Affected

The affected product is Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM, with Part Number: 150450108. It includes UDI-DI: 10603295543022, Lot Number: AF1006441, and Expiration Date: 12/31/2035. A total of 3 units are involved, distributed nationwide in the United States, specifically in the states of MN, NC, and TX. The official recall number is Z-1988-2026.

What You Should Do

Consumers who have the affected product should contact the recalling firm, DEPUY (IRELAND), as the firm initiated notification via E-Mail for further instructions on returns or refunds.

Why This Matters

This recall highlights potential risks associated with compromised sterility in medical devices, which could affect patient safety in healthcare settings.

Source

FDA Recall Number: Z-1988-2026. For more information, visit the FDA website or search for event ID 98707.

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 voluntary recall of 3 units of Depuy Synthes ATTUNE Revision Hinge Femoral device due to potential sterility issues from packaging problems.
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.