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Terminated

Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

FDA Recall Z-0706-2008 · Posted 2008-01-31

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-12-12
Date Terminated2008-06-11
Product Quantity8

Reason for Recall

Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

Firm Action

Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.

Root Cause

Packaging process control

Distribution Pattern

Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915132MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEMBiomet, Inc. · 1992-02-11

Official Source

View FDA Recall →

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

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