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.
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: The recall involves a design defect in a medical device used during surgery that was discovered during a procedure, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Encore Medical, Lp is recalling 92 units of the Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380. The affected products were distributed nationwide in the United States.
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. This design discrepancy affects part numbers 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540.
The Altivate Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction. Healthcare providers should stop using the affected trial instruments and contact Encore Medical for further instructions.
The recalled product
- Product
- Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 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
- 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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