RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Check against the official notice below — it lists the full affected range.
Encore Medical, LP is recalling 15 units of RSP Standard Humeral Socket Insert, 44MM, HXe-Plus (Part No. 509-00-044, Lot 380P1009A) because the size etched onto the products may differ from the size shown on patient sticker labels. This mislabeling could result in a surgeon implanting an incorrect size component during surgery. The recalled products were distributed in the U.S. to facilities in Virginia, Minnesota, Indiana, Rhode Island, Pennsylvania, New York, Washington, Kansas, Oklahoma, Florida, Georgia, and California.
If the wrong size component is implanted, patients could experience significant physical impairment, discomfort, disruption of their treatment, or joint dislocation that requires revision surgery. The source document does not specify what remedy or corrective action affected consumers should take.
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: 15 units Lot/code info: Part 509-00-044, Lot 380P1009A , UDI: 00888912144568
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.