—#105029

Product

The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points, distributed by DePuy International Leeds, UK. Instruments are supplied non-sterile and do not have specified expiration date or shelf life. Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia, the instrument is intended to be removed.

FDA product code: HWA — Impactor
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog number 9505-01-306 (all lots):071089, 071812, 071989, 072017, 072219, 072220, 072221, 072222, 080026, 080027, 080028, 080029, 080319, 080336, 080337, 080338, 080403, 080404, 080405, 080406, 080407, 080632, 080633, 080634, 080635, 080841, 080842, 080843, 080844, 080845, 080846, 080847, 080848, 080849, 081138, 082151, 082152, 082153, 082175, 082176, 082177, 082178, 082260, 082261, 082262, 082263, 082264, 082265, 082266, 082267, 082268, 082269, 083106, 083107, 083108, 083109, 083110, 083111, 083400, 083401, 083402, 083403, 083404, 083405, 083406, 083407, 083408, 083409, 083495, 090237, 090238, 090239, 090240, 090241, 090242, 090933, 090934, 090935, 090936, 090937, 090938, 090939, 090940, 090941, 090942, 094951, 094952, 100059, 100060, 100172, 100173, 100174, 100455, 100456, 100457, 100458, 100459, 100460, 100469, 100470, 100787, 102110, 102111, 102616, 102617, 102618, 102619, 102620, 102621, 102622, 102623, 102624, 104779, 104780, 105278, 105279, 110046, 110047, 110343, 110344, 110345, 110725, 110726, 110727, 110728, 110729, 111011, 111012, 111013, 112537, 112538, and 112539

Why it was recalled

All lots of DePuy, SIGMA HP Fixed Bearing Tibial Tray Impactors are being recalled because the impactor can become intentionally locked on the Tibial Tray implant during surgery.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, DePuy, sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" email dated December 13, 2011 to its customers. The email notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN; follow the instructions provided and complete and return the Fax Back Response card via fax to: 574-372-7567 or email: kseppa@its.jnj.com by December 23, 2011. For questions about recall information provided, please contact Manager of Customer Quality at 574-372-7333 (M-F; 8 am - 5 pm EST.) For product-related questions from Sales force, please contact Group Product Director at 574-372-7538 (M-F; 8 am - 5 pm EST.) or your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.)

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries of: Canada, Ireland and South Africa.

Timeline

Recall initiated: 2011-12-13
Posted by FDA: 2012-01-30
Terminated: 2013-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105029. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.