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Open, Classified

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

FDA Recall Z-1233-2026 · Posted 2026-02-02

Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2026-01-05
Product Quantity19

Reason for Recall

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Firm Action

On 1/5/2026, recall notices were emailed to customers who were asked to do the following: 1) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2) Contact the firm to arrange for affected device return. 3. Complete and return the acknowledgement and response form via email to [email protected] Customers with questions can email the firm at [email protected]

Root Cause

Labeling Change Control

Distribution Pattern

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Official Source

View FDA Recall →

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

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