Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T

FDA Recall Z-1821-2022 · Posted 2022-09-28

Recalling FirmOssur Americas
Recall StatusOpen, Classified
Product CodeISW
Date Initiated2022-08-29
Product Quantity190 devices

Reason for Recall

Battery may dislodge from the Power Knee

Firm Action

On 08/29/2022, The firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that reports have been received of units where the battery dislodged from the Power Knee units, causing loss of power to the device. This may cause an increase risk for stumbles or falls, potentially leading to an injury. Customer are being instructed to implement a correction to retrofit a security tab to their units. The retrofit kit will be provided with clear instructions for attaching the security tab to the device. In addition, customer are asked to: 1. Pass this notice to those who need to be aware within their organization or to any organization where Power Knee devices have been transferred. 2. Reconcile Ossur s records with their own to ensure all devices are accounted. 3. Once all users have been identified and the retrofit kits have been received, customers will need to schedule each individual to come into their clinic to complete the retrofit process. 4. Sign the acknowledgment form confirming receipt of this notice and that the retrofit process has been completed for all affected devices. Ossur is here to support customers through the process. Contact customer service for further information and assistance. Tel: 1-800-233-6263.

Root Cause

Device Design

Distribution Pattern

U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑