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Terminated

Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582

FDA Recall Z-0255-2008 · Posted 2007-11-24

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-09-18
Date Terminated2008-06-04
Product Quantity7

Reason for Recall

Mislabeled as to size: the package actaully contained a 71 mm tray.

Firm Action

Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.

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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