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FDA (Device enforcement)Recalled 2025-05-28class ii

Encore Medical, LP: Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.

Hazard

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

Details from the source

Reason for recall: Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Distribution: At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 Evolution Medical North Dakota (ND), Minnesota (MN), Colorado (CO), Utah (UT) CE106 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERA Quantity: 400 units Lot/code info: Lot Code: Item: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017

UPC codes

00190446829850

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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