AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Recommended Action

Per FDA guidance

On June 28, 2021, Encore Medical (DJO) issued a "Urgent Medical Device Recall" Notification to affected consignees, via E-Mail. In addition to informing consignees about the recall devices, the firm asked consignees to take the following actions by July 19, 2021: 1. Review your stock for the affected products and lot numbers and quarantine the items until returned. 2. Communicate the affected parts, lots, and quantities that you have in stock to your sales Agent and arrange to return all affected, unused product to your sales Agent. 3. Report any adverse events related to this issue to DJO Customer Service (1-800-456-8696). Please also note that Adverse reactions or quality problems experienced with the use of this product MAY be reported to the FDAs MedWatch Adverse Event reporting program either online, by regular mail or by fax. 4. Complete the Medical Device Recall acknowledge and receipt form (including all information in the yellow-highlighted cells) with all available information and return by e-mail to julie.baker@djoglobal.com and david.evans1@djoglobal.com by July 31, 2021.

Distribution

As reported by FDA

AL, AZ, AR, CA, CO, FL, GA, HI, IL, IN, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, PR