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.
Reported: October 28, 2020 Initiated: August 31, 2020 #Z-0117-2021
Product Description
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.
Reason for Recall
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 15
- Distribution
- US Nationwide distribution.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, LP. Units affected: 15.
Why was this product recalled? ▼
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0117-2021.
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