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Brand Name: ALTIVATE REVERSE recallZ-2010-2025 · Encore Medical, LP · initiated May 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

On May 28, 2025, Enovis (Encore Medical, L.P.) issued a "Urgent: Medical Device Recall" Notification via: E-Mail. Envois is asking consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 4. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.

Recall details

Recall number
Z-2010-2025
Status
Open, Classified
Initiated by the company
May 28, 2025
Posted by the FDA
Jun 23, 2025
Recalling firm
Encore Medical, LP
Quantity
36 units
Product code
PHX
FDA submissions
K233481
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 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

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

Code information (models, lots, serial numbers)

Lot Code: Item: 506-04-118 GTIN: 00190446829836 Lot: 5033A1020

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

20 devices cleared under K233481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96917).

Sources and updates

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