Shoulder glenoid tray kits recalled because the reamer may kick or bind
DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a surgical reamer that kicks or binds during use is a potential harm and no injuries are reported.
Plain-English summary
The DJO Surgical FA S Altivate Reverse Glenoid Tray is being recalled across all lots. Enovis shoulder devices are intended for the treatment of patients who are candidates for shoulder arthroplasty. The recall covers 439 kits distributed across more than 15 states.
The recall was issued because there is a potential that the reamer may kick or bind up during or immediately prior to use. The FDA classified the action as Class II.
Hospitals and surgical centres holding these kits should quarantine them and follow the manufacturer's instructions for return or replacement.
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
- Affected units
- 439
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
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Encore Medical, LP
See all →- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · instrument malfunction
See all →- Highda Vinci permanent cautery hook recalled over frayed pitch cables
FDA (Devices) · 2026-04-08
- Highda Vinci mega needle driver recalled over broken or frayed cables
FDA (Devices) · 2026-04-08
- Highda Vinci grasping retractor instruments recalled over broken grip cables
FDA (Devices) · 2026-04-08
- Highda Vinci double fenestrated grasper recalled over broken grip cables
FDA (Devices) · 2026-04-08
- Highda Vinci tenaculum forceps recalled over frayed or broken pitch cables
FDA (Devices) · 2026-04-08