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Open, Classified

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

FDA Recall Z-1384-2023 · Posted 2023-04-12

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeMBH
Date Initiated2023-02-28
Product Quantity29

Reason for Recall

Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.

Firm Action

On 2/28/23, field safety notices were emailed to surgical sales agents who were asked to document the quantity of affected devices complete and return the acknowledgement form. Customer service contact, [email protected], was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email [email protected].

Root Cause

Process change control

Distribution Pattern

US: TX, IN, MD, CA, KS, AL, HI, WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical · 2022-01-20

Official Source

View FDA Recall →

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

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