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Terminated

3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.

FDA Recall Z-2244-2010 · Posted 2010-08-22

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-06-28
Date Terminated2010-10-04
Product Quantity18

Reason for Recall

One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.

Firm Action

Firm notified their consignees by letter on June 28, 2010.

Root Cause

Labeling mix-ups

Distribution Pattern

Florida, Missouri, and Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0201143D KNEEEncore Orthopedics, Inc. · 2002-07-12

Official Source

View FDA Recall →

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

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