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.
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 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 arthr
- Manufacturer
- Encore Medical, LP
- Hazard
- labeling-mismatch
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
Distributed in 18 states:
- CO
- FL
- IL
- IN
- KY
- MA
- MI
- MN
- NC
- ND
- OH
- RI
- TN
- TX
- UT
- VA
- WI
- WV
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