Altivate Reverse Torx Screw (Unknown) – Labeling Size Mismatch (2025)
Product labeling contains incorrect size information which may cause minor inconvenience.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.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
Lot Codes / Batch Numbers
Lot Code: Item: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017
Products Sold
Lot Code: Item: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017
A medical device manufacturer is recalling Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalo due to Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, IL, IN, KY, MA, MI, MN, NC, ND, OH, RI, TN, TX, UT, VA, WV, WI
Page updated: Jan 10, 2026