Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
FDA Recall Z-1231-2007 · Posted 2007-09-25
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-07-31
Date Terminated2007-12-05
Product Quantity14
Reason for Recall
Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.
Firm Action
Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007.
Root Cause
Other
Distribution Pattern
Product distributed to 5 hospitals in GA, OH, MN, TX.
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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