Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling lists a different size than the actual product included inside.
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 2/5 (Moderate).
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 involving a labeling discrepancy on a medical device. No reported illnesses or injuries are stated in the source text, and the hazard is a mismatch between label and contents rather than a structural or functional defect of the device itself.
Plain-English summary
Encore Medical, LP is recalling Altivate Reverse Torx Peripheral Screws, Model/Catalog Numbers 506-04-118, 506-04-122, 506-04-126, and 506-04-130, due to package labeling that does not match the actual product size included.
The affected screws were distributed to medical device distributors and surgical facilities across the United States, including in 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 or may receive these shoulder replacement components should contact their healthcare provider or surgeon to verify the correct screw size used in their procedure. Healthcare providers and facility personnel should quarantine affected inventory and consult the FDA notice for specific lot numbers and model details.
The recalled product
- Product
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 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
- Hazard
- 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: 506-04-122 GTIN: 00190446829843 Lot: 5035A1018
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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