3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
FDA Recall Z-1539-2008 · Posted 2008-08-20
Advertisement
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2008-02-20
Date Terminated2008-09-02
Product Quantity6 units.
Reason for Recall
Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
Firm Action
Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.
Root Cause
Error in labeling
Distribution Pattern
Distribution --- country of Germany.
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.
Advertisement