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Terminated

NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.

FDA Recall Z-0915-2010 · Posted 2010-03-02

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2010-01-27
Date Terminated2010-10-17
Product Quantity14 units

Reason for Recall

The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.

Firm Action

The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.

Root Cause

Labeling mix-ups

Distribution Pattern

US and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060370NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTSZimmer, Inc. · 2006-04-28

Official Source

View FDA Recall →

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

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