17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
FDA Recall Z-0107-04 · Posted 2003-11-13
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Recalling FirmPlus Orthopedics
Recall StatusTerminated
Product CodeKRO
Date Initiated2003-08-01
Date Terminated2004-12-12
Product Quantity35
Reason for Recall
Plastic insert over articular surface of knee joint replacement may become dislodged.
Firm Action
Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
Root Cause
Other
Distribution Pattern
AZ, ID, TX CTdistributors.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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