Shoulder Replacement Screw Labeling Does Not Match Product Size
Encore Medical is recalling ALTIVATE REVERSE TORX PERIPHERAL SCREW surgical components because package labeling lists a different size than what is actually included. The mismatch could result in selection of an incorrectly sized component during shoulder replacement surgery.
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: This is an FDA Class II device recall involving a mismatch between package labeling and the actual product. The potential for incorrect surgical component selection creates a risk-of-harm scenario. Per the severity rubric, FDA Class II recalls without reported hospitalizations classify as High severity (score 3).
Plain-English summary
Encore Medical, LP is recalling ALTIVATE REVERSE TORX PERIPHERAL SCREW components used in shoulder replacement surgery. The product is available in 18mm, 22mm, 26mm, and 30mm sizes. Some packages have labeling that indicates a different size than the surgical screw actually contained inside.
The labeling discrepancy creates potential for use of a mismatched component during surgery. Use of an incorrectly sized surgical component could affect the outcome of a shoulder replacement procedure.
Prior to identification and quarantine, approximately 200 units were distributed to medical facilities in Virginia, North Dakota, Minnesota, Colorado, Utah, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, Rhode Island, and Massachusetts.
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
- Hazard
- mis-labeling
- 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: 506-04-130 GTIN: 00190446829867 Lot/s: 5039A1015 / 5039A1021
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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