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Terminated

Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.

FDA Recall Z-0711-2017 · Posted None

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-11-15
Date Terminated2017-01-20
Product Quantity7 units

Reason for Recall

A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.

Firm Action

The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ

Official Source

View FDA Recall →

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

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