Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 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
Why it was recalled
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Lot Code: Item: 506-04-130 GTIN: 00190446829867 Lot/s: 5039A1015 / 5039A1021
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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
Recall record
- Recalling firm
- Encore Medical, LP
- Product type
- Devices
- Recall number
- Z-2011-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Austin, TX
- Recall initiated
- 2025-05-28
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2011-2025 · Source: openFDA enforcement.