Device product
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Z-0117-2021
Product summary
- Event
- Event 86395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-0117-2021
Official wording
Reason: Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Code information: Lot Number: 964W1000
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
mislabeled