ALTIVATE Reverse shoulder screw package labeled with incorrect size
Encore Medical is recalling ALTIVATE REVERSE TORX PERIPHERAL SCREWS due to packaging labeling errors. The label indicates one screw size, but the actual product included is a different size than stated.
What this means for you
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: FDA Class II surgical device with a labeling mismatch where the package designation does not match the actual product size. This is a risk-of-harm situation for shoulder replacement surgery, but no injuries have been reported to date.
Plain-English summary
Encore Medical, LP is recalling approximately 400 units of ALTIVATE REVERSE TORX PERIPHERAL SCREWS (26mm model 506-04-126) due to a packaging labeling error. The product labeling states one screw size, but the actual product included in the package is a different size.
The ALTIVATE REVERSE is an orthopedic surgical device intended for shoulder replacement procedures. Using an incorrectly sized screw during shoulder surgery could compromise the fit and stability of the implant, potentially affecting surgical outcomes.
The affected screws were distributed to medical device distributors and surgical centers across multiple states, including Virginia, North Dakota, Minnesota, Colorado, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, Massachusetts, and Rhode Island.
Surgeons and surgical centers who have this product should stop using it immediately and contact their device distributor. No injuries or illnesses have been reported to date.
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 arthr
- Manufacturer
- Encore Medical, LP
- Hazard
- mis-labeling
- implant-size-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: 506-04-126 GTIN: 00190446829850 Lot\s: 5037A1011 / 5037A1017
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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