REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics Warsaw, IN 46581. The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
FDA Recall Z-1438-2012 · Posted 2012-04-19
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2012-03-20
Date Terminated2013-02-07
Product Quantity64 units distributed
Reason for Recall
Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging
from its intended position (post-initial surgery). An investigation was initiated and the available lots of
the Lock Pin were evaluated and measured against print specifications.
Firm Action
Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983.
Root Cause
Component design/selection
Distribution Pattern
Distributed in California and Pennsylvania.
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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