Encore Medical, LP Recalls Reverse Shoulder Prosthesis (RSP) Humeral Socket Inserts Due to Labeling Error
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Encore Medical, LP has issued a voluntary recall for 20 units of its Reverse Shoulder Prosthesis (RSP) humeral socket inserts because of incorrect labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 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, MedicalDevices.
What Happened
Encore Medical, LP, based in Austin, Texas, has initiated a voluntary recall of its Reverse Shoulder Prosthesis (RSP) humeral socket inserts. The recall was prompted by the discovery that certain knee and humeral socket implants contain incorrect labeling. This Class II recall was officially classified by the FDA on February 24, 2026.
Which Products Are Affected
The recall affects 20 implants with the following specifications:
- Brand Name: Reverse Shoulder Prosthesis (RSP)
- Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus
- Model/Catalog Number: 509-00-036
- Lot Code: 378P1382
- GTIN: 00888912144544
Distribution: The affected products were distributed to healthcare facilities in the following states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Encore Medical, LP initiated the recall on January 15, 2026, by notifying affected customers via a formal letter. Healthcare providers and surgical facilities should immediately check their inventory for the affected lot code (378P1382). If the product is found, it should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information, facilities should contact Encore Medical, LP directly at their Austin, TX headquarters.
Why This Matters
Incorrect labeling on medical implants is a significant concern as it can lead to the selection of the wrong component during surgical procedures, potentially resulting in patient injury or the need for revision surgery.
Source
Information provided by the FDA. Recall Number: Z-1460-2026.
Original source: FDA Official Notice ↗
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