EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
FDA Recall Z-0970-2015 · Posted 2015-01-14
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Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-12-01
Date Terminated2015-05-06
Product Quantity553
Reason for Recall
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Firm Action
On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory.
Root Cause
Process design
Distribution Pattern
TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.
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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