EMPOWR 3D KNEE Recall Due to Packaging Discrepancy
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Encore Medical, LP is recalling 11 units of EMPOWR 3D KNEE devices due to incorrect product sizes in packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 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
Encore Medical, LP initiated a voluntary recall of certain EMPOWR 3D KNEE devices because of a packaging discrepancy with incorrect product size mixed up. The recall is classified as Class II by the FDA and remains ongoing.
Which Products Are Affected
The recall affects 11 total units of EMPOWR 3D KNEE INS devices distributed to specific firms in states including Indiana (IN), Michigan (MI), Colorado (CO), Wyoming (WY), Montana (MT), Nebraska (NE), New York (NY), Alabama (AL), Illinois (IL), Texas (TX), South Dakota (SD), North Carolina (NC), and others. Affected catalog numbers include 342-19-703 (Lot: 177T1057, GTIN: 00888912167703, Exp: 12/07/2026), 341-14-711, and 342-14-711. Product description: Enovis knee devices intended for knee arthroplasty. Recall number Z-2700-2026.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
The recall involves devices used in knee arthroplasty procedures distributed across multiple states.
Source
FDA recall Z-2700-2026. https://www.fda.gov
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 (1,078 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.