Z-1906-2012Class II

ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays...

Name: Z-1906-2012 ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays...
Creator: DePuy Orthopaedics, Inc.
Published: 2012-05-16
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2012-05-16 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors... on 2012-05-16. FDA classified it as Class II and gives the reason as "DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM)...". 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-1906-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-16
Posted: 2012-06-29
Terminated: 2013-03-05
Recalling firm: Depuy Orthopaedics Inc.
Product: ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
Root cause tag: design
FDA root cause: Device Design
Action: DePuy sent an "URGENT RECALL INFORMATION-FIELD SAFETY NOTICE" letter dated May 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 574-372-7333 for questions regarding this notice.
Quantity in commerce: 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Distribution: Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
Product codes and lots: Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1907-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1908-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1909-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1910-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1911-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1912-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1913-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1914-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1915-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1916-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1917-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1918-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1919-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1920-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1921-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1922-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1923-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1924-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29

Product code JDI

K972435Class IIUltima and Ultima Lx Cemented Femoral StemJohnson & Johnson Professionals, Inc. / cleared 1997-09-11

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)