Altivate Reverse Torx Peripheral Screw package labeling mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because the package labeling lists a different size than the actual product included inside.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a labeling discrepancy for a critical surgical implant component. The source states no illnesses or injuries reported, and the hazard is a potential mismatch in component sizing rather than contamination or structural failure. Labeling errors without reported adverse events typically fall in the Moderate range.
Plain-English summary
Encore Medical, LP is recalling Altivate Reverse Torx Peripheral Screws (Model/Catalog Number 506-04-130, 30mm) due to a labeling discrepancy. The package labeling indicates a different screw size than what is actually included in the package.
The recalled screws are shoulder implant components intended for use in shoulder arthroplasty procedures. The labeling mismatch creates a risk of using an incorrect component size during surgery, which could compromise the proper fit and function of the shoulder implant.
The affected screws were distributed to medical distributors and surgical supply facilities 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, among other locations.
Patients who have received shoulder implant surgery using these screws, or healthcare providers who may have unused inventory, should contact Encore Medical, LP or their surgical distributor immediately for further instructions.
The recalled product
- Product
- 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 arthr
- Manufacturer
- Encore Medical, LP
- Affected units
- 200
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: 506-04-130 GTIN: 00190446829867 Lot/s: 5039A1015 / 5039A1021
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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