Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall where a surgical component's mislabeling creates significant risk of incorrect implantation during shoulder replacement procedures. The source text explicitly indicates a labeling-to-product mismatch that could result in wrong-sized implant use, which represents a risk-of-harm scenario; no adverse events are reported in the source.
Plain-English summary
Encore Medical, LP is recalling Altivate Reverse Torx Peripheral Screws (Model 506-04-126, 26mm) due to a labeling defect. The package labeling for the recalled screws contains a different size designation than the actual product included in the package.
This mismatch between labeled and actual product size poses a risk during shoulder arthroplasty procedures, as surgeons may select and implant an incorrectly sized component based on the package label rather than the actual screw dimensions. The recalled screws were distributed to medical device wholesalers and distributors across multiple states including Virginia, North Dakota, Minnesota, Colorado, Utah, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, Rhode Island, and Massachusetts.
Patients who have received this implant or healthcare providers who have used these screws in procedures should contact Encore Medical, LP. Hospitals and surgical centers that received the affected inventory should quarantine the product and verify actual screw sizes before use in any surgical procedures.
The recalled product
- 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…
- Manufacturer
- Encore Medical, LP
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Item: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017
Distribution
Part of a larger recall action
This product is one of 4 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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