Altivate Reverse shoulder implant screw package labeling mismatch FDA recall
Altivate Reverse Torx Peripheral Screw packages are labeled with incorrect size information. The included product may differ from the labeled size, posing risks if implanted in error.
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 medical device recall for a surgical implant with a size-mismatch labeling error. The defect poses a clear risk of harm (wrong-size component could compromise surgery), but no injuries have been reported, fitting the Score 3 criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Encore Medical, LP has recalled Altivate Reverse Torx Peripheral Screws due to package labeling errors. The packages are labeled with one size, but the actual screw included may be a different size. This size mismatch poses a risk because surgeons depend on accurate package labeling to select the correct component size for shoulder replacement procedures.
The recall affects 36 units distributed through multiple medical device distributors across the United States, including facilities in Virginia, North Dakota, Minnesota, Colorado, Utah, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, and Massachusetts. The affected products were identified at the time of quarantine at distributor facilities.
Healthcare providers and hospitals that received affected units should immediately stop use and verify that all Altivate Reverse Torx Peripheral Screw packages contain the size labeled before implantation in any patients. No injuries or adverse events have been reported to date. Patients who have received this device should consult with their surgeon regarding their specific implant.
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 arthr
- Manufacturer
- Encore Medical, LP
- Hazard
- mis-labeling
- wrong-size
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
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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