Shoulder Replacement Screws Recalled for Package Size Mislabeling
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws used in shoulder replacement surgery because the package labeling indicates a different size than the product it contains.
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 a risk-of-harm product where injury has not yet been reported. A surgical implant with mislabeled size could lead to use of incorrect components during shoulder replacement procedures, but no illnesses or injuries have been reported to date.
Plain-English summary
Encore Medical, LP is recalling Altivate Reverse Torx Peripheral Screws (Model numbers 506-04-118, 506-04-122, 506-04-126, and 506-04-130) used in shoulder replacement procedures. These implant components were distributed to medical device distributors across the United States.
The recall was initiated because package labeling for these screws indicates one size, while the actual product inside the package is a different size. This mislabeling creates confusion about what implant component is being used during surgery.
The affected screws were distributed to medical device distributors in multiple states including Virginia, North Dakota, Minnesota, Colorado, Utah, Texas, Wisconsin, Tennessee, Florida, Illinois, Indiana, Michigan, West Virginia, Kentucky, Ohio, North Carolina, Rhode Island, and Massachusetts. A total of 200 units were involved in the recall.
Healthcare providers and surgical facilities that have received these screws should verify their inventory against the lot numbers and model numbers listed in this recall. Products where the package labeling does not match the actual size should not be used and should be reported to Encore Medical.
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
- mislabeling
- wrong-size-product
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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