Agency classClass IIOur severity:High FDA (Devices)·Z-2331-2021·Announced 2021-09-01

FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure

The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an orthopedic implant with a structural defect that could delay or complicate surgery. No illnesses or injuries have been reported, placing this at the High severity level per the rubric for risk-of-harm products without yet-manifested injury.

Plain-English summary

Encore Medical, LP is recalling the AltiVate Anatomic Shoulder System (Part Numbers 520-08-00, 520-10-000, 520-12-000, 520-14-000, and 520-16-000) due to a defect in the humeral stem component.

The humeral stem may fail to mate properly with the broach handle during shoulder replacement surgery. This could result in delays to the surgical procedure or the need for revision surgery.

The recalled devices have been distributed across the United States, including Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and West Virginia.

Patients or healthcare providers who have received or implanted one of these devices should contact Encore Medical, LP for further instructions. Healthcare providers should review their records to identify affected implants and consult with the manufacturer regarding appropriate management.

The recalled product

Product: 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
Manufacturer: Encore Medical, LP
Category: Medical Device — Orthopedic Implant / Shoulder System
Hazard: mechanical-failure
surgical-delay-risk
device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part number/ Lot number: 1. 520-08-000 / 85OU1108
85OU1110
85OU1111
2. 520-10-000 / 851U1256
851U1257
851U1258
851U1259
3. 520-12-000 / 852U1402
852U1393
852U1404
852U1395
852U1398A
852U1405
852U1397
852U1391
852U1400
852U1398
852U1407
852U1396
852U1406

Distribution

Distributed in 35 states:

Same manufacturer · Encore Medical, LP

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