medical Class II Updated 2020-10-07

Encore Medical, LP recalls RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No.

Recalled Product

RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044


Hazard / Issue

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.

Issued by

FDA

Affected States: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA, CA
Lot/Code Info: Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
View official government recall

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