OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
FDA Recall Z-0417-2012 · Posted 2012-01-11
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2011-11-01
Date Terminated2012-09-10
Product Quantity3 units & 1 pending release
Reason for Recall
Biomet has initiated this action following an investigation which identified that Part 150367, (OSS
Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem
14x150).
Firm Action
Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Distributed only in The Netherlands.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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