Altivate Reverse Torx Peripheral Screws Package Labeling Mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.
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 involving orthopedic surgical implants where mislabeling creates risk of harm through incorrect surgical selection and implantation. No reported illnesses or injuries are stated in the source, but the hazard is that surgeons could implant incorrectly sized components during shoulder replacement surgery, which is a direct risk-of-harm scenario for a high-risk product category.
Plain-English summary
Encore Medical, LP is recalling Altivate Reverse Torx Peripheral screws due to a labeling discrepancy. The package labeling for certain lots indicates a different screw size than the actual product contained within.
The affected screws are used in shoulder replacement procedures. This mislabeling could lead to surgeon selection and implantation of incorrectly sized components during shoulder arthroplasty, potentially compromising the surgical outcome.
The recalled devices have been distributed to medical distributors and surgical facilities across multiple states. Affected lot codes and catalog numbers are detailed in the distribution records. Healthcare providers who have received these screws should review their inventory against the lot information and contact their supplier if they have potentially affected units.
Patients who have received implants from affected lots should consult with their surgeon. Surgeons and facilities are advised to quarantine affected inventory and verify the actual screw size contents against package labeling before any future use.
The recalled product
- Product
- 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…
- Manufacturer
- Encore Medical, LP
- Affected units
- 36
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: 506-04-118 GTIN: 00190446829836 Lot: 5033A1020
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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