DJO Surgical is recalling 447 ALTIVATE Reverse Glenoid Reamer Sleeve devices distributed nationwide in the United States. The device may kick or bind up during or immediately prior to use. Healthcare providers and patients should stop using the device and follow recall instructions issued by Encore Medical, LP via email.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Encore Medical, LP or your healthcare provider for instructions. Notification method: E-Mail
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The ALTIVATE Reverse Glenoid Reamer Sleeve is a surgical instrument used in shoulder arthroplasty to prepare the glenoid. Hospitals and surgeons rely on precise instrumentation for joint replacement procedures.
The device has a potential to kick or bind up during use, which could lead to unexpected movement during a surgical procedure and possible patient or operator injury.
This recall is not presented as part of a broader industry pattern.
If used, the potential for intraoperative distraction or injury could disrupt procedures and require device replacement or surgical revisions.
Recall notice via Encore Medical email and FDA enforcement pages
Manufacturer guidance will outline replacement or remediation timelines; follow all instructions as issued
Keep the recall notice, batch/lot numbers, and all email communications; photograph labels and packaging for records
Model/catalog number: 804-06-310. Distribution: US nationwide in AL, AZ, CA, CO, FL, HI, IA, IL, IN, KS, KY, LA, ME, NE, NJ, NY, OH, PR, RI, SC, TN, TX, UT, VA, WA, WI. Sold since: Unknown. Price: Unknown. Quantity: 447 units.
No injuries or incidents have been reported.
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