RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Check against the official notice below — it lists the full affected range.
Encore Medical, LP is recalling 37 units of RSP Standard Humeral Socket Insert, 40 MM plus 4MM, HXe-Plus (Part No. 509-00-440) due to mislabeling. The products may have size markings etched onto them that differ from the size information shown on patient sticker labels. The affected lot numbers are 387P1042A and 387P1045A, and these units were distributed in the U.S. to Alabama, California, Florida, Georgia, Indiana, Kansas, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, Virginia, and Washington.
If a surgeon implants an incorrect size socket insert due to this mislabeling, patients could experience significant physical impairment, discomfort, disruption of treatment for their underlying condition, or dislocation that requires revision surgery. The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA Quantity: 37 units Lot/code info: Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.