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Open, Classified

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

FDA Recall Z-0102-2024 · Posted 2023-10-12

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-08-22
Product Quantity36

Reason for Recall

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Firm Action

On 8/22/23, recall notices were emailed to agents who were asked to do the following: 1) Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. 2) The notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. If you have any questions, email [email protected]

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Official Source

View FDA Recall →

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

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