Shoulder Surgical Device Recalled Due to Potential Reamer Binding
Encore Medical is recalling the DJO SURGICAL FA S Altivate Reverse Glenoid Tray shoulder replacement device. The surgical reamer may kick or bind during use.
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: Class II FDA medical device recall for orthopedic surgical equipment with potential reamer malfunction during high-risk surgery. No reported injuries or hospitalizations documented, but the hazard presents a risk-of-harm scenario during shoulder replacement procedures on anesthetized patients.
Plain-English summary
Encore Medical, LP is recalling 439 kits of the DJO SURGICAL FA S Altivate Reverse Glenoid Tray, a shoulder replacement device distributed nationwide across multiple U.S. states.
The recall is due to a potential malfunction in the surgical reamer. The reamer may kick or bind up during or immediately prior to use during shoulder replacement surgery.
This is a Class II FDA recall. Patients and healthcare providers should be aware of this potential equipment malfunction during the surgical procedure.
The recalled product
- Product
- Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for u
- Manufacturer
- Encore Medical, LP
- Hazard
- equipment-malfunction
- binding
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: All GTIN:
Distribution
Distributed nationwide across the United States.
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