Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RSP Standard HUMERAL SOCKET INSERT Recalled by Encore Medical, LP Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, LP directly.
Affected Products
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Quantity: 37 units
Why Was This Recalled?
Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.
Where Was This Sold?
This product was distributed to 12 states: CA, FL, GA, IN, KS, MN, NY, OK, PA, RI, VA, WA
About Encore Medical, LP
Encore Medical, LP has 54 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report