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Terminated

Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant

FDA Recall Z-0766-2017 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-09-19
Date Terminated2017-10-20
Product Quantity162 units

Reason for Recall

It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery.

Firm Action

DJO Global sent an Urgent Field Safety Notice dated September 19, 2016, to all affected customers. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device. Customers were instructed to become familiar with the new surgical techniques and notify all of their applicable users of the revised methods. Customers were also instructed to sign the Acknowledgement and Receipt Form. Customers with questions were advised to call 760-734-3551. For questions regarding this recall call 512-832-6302.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160342EMPOWR PS Knee SystemEncore Medical L.P. · 2016-05-19

Official Source

View FDA Recall →

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

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