Z-0930-2012

The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the...

Name: Z-0930-2012 The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the...
Creator: DePuy Orthopaedics, Inc.
Published: 2011-12-13
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2011-12-13 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of 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... on 2011-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0930-2012
Status: Terminated
Initiated: 2011-12-13
Posted: 2012-01-30
Terminated: 2013-07-12
Recalling firm: Depuy Orthopaedics Inc.
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.
Product code: HWA Impactor
Reason for recall: 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 tag: design
FDA root cause: Device Design
Action: 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: [email protected] 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.)
Quantity in commerce: 1794
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Ireland and South Africa.
Product codes and lots: 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

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)