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.
FDA Recall Z-0117-2021 · Posted None
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Recalling FirmEncore Medical, LP
Recall StatusTerminated
Product CodeKWS
Date Initiated2020-08-31
Date Terminated2024-04-19
Product Quantity15
Reason for Recall
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Firm Action
On 08/31/2020, the firm notified affected customers via email using a letter titled, "URGENT FIELD SAFETY NOTICE", indicating the following:
The firm requires that you do the following actions by September 11, 2020:
1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred.
2. Review your stock for the affected products and lot numbers and to quarantine the items until returned.
3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product.
4. Return all affected devices quantities using the RMA number.
Your actions above will demonstrate that you have received and understand this notification.
If you have any questions, please contact the company's Regulatory Affairs Manager via email. Company telephone number is 1-800-321-9549.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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