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.

Terminated

EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.

FDA Recall Z-0328-2018 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-12-12
Date Terminated2022-06-13
Product Quantity2 units

Reason for Recall

The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

Firm Action

The field safety notice was disseminated by email on 12/12/2017. The notice stated the following: "DJO Sales Agents Action: Please review the bulletin that is provided with this notice. This bulletin contains new instructions on the use of the Locking Punch Guide and Punch. Please ensure your surgeons are familiar with this information. DJO Surgical then requires that you complete the attached acknowledgment and email it to [email protected]. Please have this form returned by December 15, 2017 Once redesigned guides are available, they will be exchanged through a separate field action."

Root Cause

Device Design

Distribution Pattern

One medical device distributor in California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100900MOTIVATION KNEE SYSTEMEncore Medical L.P. · 2010-06-18

Official Source

View FDA Recall →

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

↑