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

Class II FDA enforcement event 61749. Recall start date: 16 May 2012. Status in the FDA record: Terminated. Termination date: 5 Mar 2013.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

DePuy Orthopaedics, Inc. started this device recall on 16 May 2012. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 61749 has 19 product records. The first FDA enforcement report date is 11 Jul 2012. The record gives the status Terminated, with the termination date 5 Mar 2013.

FDA enforcement report The 19 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

Recalling firm

DePuy Orthopaedics, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

19 product records in the event.

FDA event 61749: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1906-2012	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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1907-2012	ULTIMA*LX STM,POL 10/12TAP/SZ2 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1908-2012	ULTIMA*LX STM,POL 10/12TAP/SZ3 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1909-2012	ULTIMA*LX STM,POL 10/12TAP/SZ4 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1910-2012	ULTIMA*LX STM,POL 10/12TAP/SZ5 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1911-2012	ULTIMA*LX STM,POL 10/12TAP/1M 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1912-2012	ULTIMA*LX STM,POL 10/12TAP/2M 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1913-2012	ULTIMA*LX STM,POL 10/12TAP/3M 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1914-2012	ULTIMA*LX STM,POL 10/12TAP/4M 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…	431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots	Class II	Terminated	11 Jul 2012
Z-1915-2012	LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1916-2012	LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1917-2012	LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1918-2012	LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1919-2012	LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1920-2012	LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1921-2012	LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1922-2012	LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1923-2012	LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	(85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012
Z-1924-2012	LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which…	85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots	Class II	Terminated	11 Jul 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 19Median of the firm: 1
Events of the firm on the register: 59

Other events of the firm

Other FDA enforcement events of DePuy Orthopaedics, Inc.
Initiated	Product (first record)	Type	Class	Records
12 Mar 2024	ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen	Device	Class II	1
15 Feb 2023	Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118	Device	Class II	5
29 Jun 2022	ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f	Device	Class II	1
18 May 2022	MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136	Device	Class II	1
11 Mar 2022	VELYS Robotic-Assisted Solution Base Product No.: 451570100	Device	Class II	1
5 Jan 2022	ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision su	Device	Class II	2
7 Dec 2021	GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610	Device	Class II	8
9 Sep 2021	ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001	Device	Class II	1
10 Aug 2021	TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical	Device	Class II	7
1 Jul 2021	ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080	Device	Class II	1

DePuy Orthopaedics, Inc.: all 59 events

Official channels

FDA enforcement report Z-1906-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 61749. https://recallregister.com/fda/ii/61749/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
What quantity of product is in FDA event 61749?: The event has 19 product records. The first record gives this quantity: 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.