Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments
Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving surgical instruments where design discrepancies can impact procedural safety.
Plain-English summary
Encore Medical, Lp is recalling 93 units of Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540. The recall covers all serial numbers and includes distribution across the US nationwide. The product is 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 source text lists part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540 in relation to this design discrepancy.
This is an FDA Class II recall. Healthcare providers and patients should stop using the affected instruments and contact Encore Medical, Lp for further instructions or replacement.
The recalled product
- Product
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 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
- Hazard
- Affected units
- 93
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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