Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments
Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a design discrepancy in a surgical instrument that could affect the accuracy of the implant placement, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Encore Medical, Lp is recalling 92 units of the Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500. The affected products are part of the AltiVate Anatomic Shoulder System, which is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
The recall was initiated after it was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial is much larger on the trials than on the implants. The recall covers part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540, with all serial numbers affected.
The products were distributed nationwide in the United States. Healthcare providers and patients should contact Encore Medical, Lp for further instructions regarding the return or replacement of these instruments.
The recalled product
- Product
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 92
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)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Encore Medical, Lp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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