Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
FDA Recall Z-0325-2017 · Posted None
Advertisement
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-09-19
Date Terminated2017-10-20
Product Quantity436 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. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
Firm Action
The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device.
Root Cause
Under Investigation by firm
Distribution Pattern
US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement