Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
FDA Recall Z-0399-2007 · Posted 2007-02-08
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-12-04
Date Terminated2007-02-21
Product Quantity23 units
Reason for Recall
A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
Firm Action
Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
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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