Encore Medical, LP: Device Recall

Recall #Z-2010-2025 · 05/28/2025

Class II: Risk

Recall Details

Recall Number: Z-2010-2025
Classification: Class II
Product Type: Device
Recalling Firm: Encore Medical, LP
Status: Ongoing
Date Initiated: 05/28/2025
Location: Austin, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36 units

Reason for Recall

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

Product Description

Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA

Distribution Pattern

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 PERIPHERAL SCREW, 30mm 4 Valor Medical Solutions South Texas (TX) CE118 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 1 Joint Ventures Medical LLC Wisconsin (WI) CE121 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 24 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 WHISKEY TRAIL ORTHOPEDICS LLC - AUS Tennessee (TN) CE123 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 8 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 4 McCants Medical, LLC Florida (FL) CE128 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 4 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 Florida Direct - FSW Medical Florida (FL) FL001 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 16 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 72 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 27 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 65 Great Lakes Medical Illinois (IL) GL108 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 8 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 6 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 14 Certus Medical LLC Indiana (IN) & Michigan (MI) GL112 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 17 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 3 506-04-130 5039A1021 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 23 I & S Medical West Virginia (WV) & Kentucky (KY) GL113 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 1 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 8 Osteo Solutions Ohio (OH), Kentucky (KY), GL114 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 15 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 16 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 6 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 32 Procore Medical, LLC North Carolina (NC) MA102 506-04-118 5033A1020 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm 1 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 14 506-04-126 5037A1017 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 2 506-04-130 5039A1015 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm 59 Medsource Rhode Island (RI), Massachusetts (MA) NE131 506-04-122 5035A1018 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm 3 506-04-126 5037A1011 ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm 12 506-04-126 5037A1017 ALTIVATE REVERSE TORX PER

Other Recalls by Encore Medical, LP

Class II: Risk 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

View all recalls by Encore Medical, LP →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.